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AzTrials

Infection, Human Immunodeficiency VirusPhase 1NCT02478463

Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

A Phase 1 study testing Cabotegravir tablet 30 mg once daily for 28 days. and Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1. in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Cabotegravir tablet 30 mg once daily for 28 days. and Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesUnited States
Study dates
27 Feb 2017to 25 Jul 2019
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 18 and 55 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
  • A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the medical monitor agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. A single repeat of a procedure or lab parameter is allowed to determine eligibility.
  • Body weight >= 40 kilogram (kg) and body mass index (BMI) within the range 18.5 to 35 kg /meter square (inclusive).
  • Male or female
  • A female subject is eligible to participate if she is pre-menopausal, has an intact uterus and cervix, AND is not pregnant (as confirmed by a negative human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies: a) Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation, Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Documented Bilateral Oophorectomy. b)Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer (can be up to 66 weeks on study) after the last dose of study medication and completion of the follow-up visit. Female subjects desiring pregnancy or foresee that they might wish to become pregnant within 52 weeks of receiving a CAB LA injection must be excluded. All subjects participating in the study must be counseled on safe sexual practices including the use of effective barrier methods to minimize risk of HIV transmission.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.

Who cannot join

  • Liver Function: ALT or AST > upper limit of normal (ULN)
  • Total bilirubin >ULN (isolated total bilirubin >ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%)
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • Corrected QT (QTc) Interval: QTc > 450 milliseconds (msec):
  • NOTES: The QTc is the QT interval corrected for heart rate according to Bazette's formula (QTcB), machine-read or manually over-read. QTcB will be used to determine eligibility for an individual subject. Exclusion criteria for screening electrocardiogram (ECG) (a single repeat is allowed for eligibility determination): Heart rate (<45 and >100 beats per minute (bpm) for males and <50 and >100 bpm for females; QRS duration: >120 msec; QTc interval: >450 msec for males and females
  • The subject's systolic blood pressure is outside the range of 90-140 millimeter (mm) mercury (Hg), or diastolic blood pressure is outside the range of 45-90 mmHg.
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  • History of clinically significant cardiovascular disease including:
  • Evidence of previous myocardial infarction (pathologic Q waves, S-T segment changes (except early repolarization); History/evidence of symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PCTA) or any clinically significant cardiac disease; Any conduction abnormality (including but not specific to left or right complete bundle branch block, AV block (2nd degree [type II] or higher), Wolf Parkinson White [WPW] syndrome); Sinus pauses > 3 seconds.
  • Any significant arrhythmia which, in the opinion of the principal Investigator and GSK Medical Monitor, will interfere with the safety for the individual subject. Non-sustained (>=3 consecutive ventricular ectopic beats) or sustained ventricular tachycardia.
  • History of ongoing or clinically relevant seizure disorder within the previous 2 years, including subjects who have required treatment for seizures within this time period. A prior history of seizure, with a seizure free period of at least 2 years, off anti-epileptics, may be considered for enrolment if the investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the medical monitor prior to enrolment
  • Use of any concurrent prohibited medications as outlined in protocol
  • History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 milliliter [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
  • Inability or unwillingness to comply with lifestyle and/or dietary restrictions outlined in protocol.
  • High-risk behavior for HIV infection which includes, but is not limited to, one of the following risk factors within six months before entering the study (Day 1 of the oral lead-in): Unprotected vaginal or anal sex with a known HIV infected person or a casual partner, engaged in sex work for money or drugs, acquired a sexually transmitted disease, high risk partner currently or in the previous six months or intravenous drug use.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
  • For subjects participating in magnetic resonance imaging (MRI) imaging: Contraindication for MRI scanning (as assessed by local MRI safety questionnaire), which includes but is not limited to: a) Intracranial aneurysm clips (except Sugita) or other non-MRI compatible metallic objects; b) Intra- orbital metal fragments that have not been removed by a medical professional; c) Pacemakers or other implanted cardiac rhythm management devices and non-MRI compatible heart valves, d) Inner ear implants, e) History of claustrophobia
  • Positive hepatitis B surface antigen or positive hepatitis B core antibody with negative hepatitis B surface antibody test result at screening or within 3 months prior to first dose of study treatment.
  • Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment
  • A positive pre-study drug/alcohol screen. A positive drug screen is permitted if due to a prescribed medication, provided that medication is not on the list of prohibited medications and approved by the investigator and medical monitor.
  • A positive test for HIV antibody.
  • A positive pre-study screen for sexually transmitted diseases including Neisseria gonorrhea or Chlamydia trachomatis, Trichomonas, syphilis, or an active Herpes simplex virus (HSV) genital lesion.
  • Presence of a tattoo or other dermatological condition overlying the buttocks which in the opinion of the investigator may interfere with the interpretation of injection site reactions.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.
  • Additional Criteria for Female Subjects Only:
  • Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the genital tract sampling (e.g., active genital tract infection or lesions).
  • Inability to abstain from the use of intravaginal products (e.g. tampons, spermicides, lubricants, vaginal hygiene products, diaphragms) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after.
  • Inability to abstain from any sexual activity (e.g., vaginal intercourse, masturbation, and penetration of the vagina by penises, fingers, tampons, sex toys) for 72 hours prior to the genital tract sample collection visits and for up to 72 hours after.
  • Additional Criteria for Male Subjects and Female Subjects who consent to rectal PK sampling:
  • Any current medical conditions that in the opinion of the investigator may compromise the conduct or analysis of the rectal compartment sampling (e.g., active rectal compartment infection, lesions or disease).
  • Inability to abstain from the use of intrarectal products (e.g., suppositories, lubricants) for 72 hours prior to the rectal compartment sample collection visits and for up to 72 hours after.
  • Inability to abstain from any receptive anal sexual activity (e.g., anal receptive intercourse and penetration of the rectum by fingers, sex toys or other) for 72 hours prior to the rectal compartment sample collection visit and for up to 72 hours after.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • GSK Investigational Site

    Baltimore, Maryland, 21287-5554

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: A Phase 1, Multicompartmental Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements. Currently, the CAB concentrations achieved in the anatomical sites associated with sexual HIV transmission following the proposed 600 milligram (mg) intramuscular (IM) PrEP dose are unknown. These data will enhance our understanding of CAB distribution to the anatomical mucosal tissue believed to be relevant to sexual HIV-1 transmission and supplement the data to support future PrEP clinical trial development. The primary objective is to determine the PK concentrations of CAB following LA administration in plasma and in vaginal tissue (VT), cervical tissue (CT), and cervicovaginal fluid (CVF) in healthy women and in rectal tissue (RT) and rectal fluid (RF) in healthy men and women following a single 600 mg IM dose. This will be a Phase 1, open label study in healthy subjects to assess the pharmacokinetics of CAB LA in the plasma and mucosal locations associated with sexual HIV-1 transmission: VT, CT, CVF, RT and RF. The study will consist of a screening period, a 28-day oral lead-in phase at a dose of 30 mg per day followed by a 14-42 day washout period, and a single dose of CAB LA 600 mg as an IM (intragluteal) injection with compartmental pharmacokinetic (PK) sampling for up to 12 weeks. Subjects will return for safety assessments and plasma PK sampling at Week 24 and Week 36 post-injection and undergo a follow-up/withdrawal visit at Week 52 post-injection.

Being tested
Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
Keywords
Cabotegravir, Pharmacokinetic, Healthy Adult Volunteers, GSK1265744
Medical subject headings
Infections, Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cabotegravir tablet 30 mg once daily for 28 days.Drug

    GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237

  • Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.Drug

    Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL [600 mg] total) IM given once on Day 1 of injection phase

Study groups in NCT02478463
Study groupRoleWhat they receive
CabotegravirExperimentalSubject will receive CAB 30 mg tablet once daily oral dose for 28 days (4 weeks) followed by a washout period of 14 to 42 days. After the washout, subject will receive a single dose of CAB LA 600 mg IM to gluteal region.
Receives: Drug: Cabotegravir tablet 30 mg once daily for 28 days.; Drug: Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cabotegravir Concentration in Blood Plasma Following IM Administration

    Blood samples were collected to measure cabotegravir concentration in blood plasma following a single 600 mg IM dose at indicated time-points. Evaluable Pharmacokinetic (PK) Plasma Parameter Summary Population comprised of all participants who underwent plasma PK sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and had evaluable PK parameters estimated and no major protocol deviation.

    Measured: Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose

  2. Cabotegravir Concentration in Vaginal Tissue Following IM Administration (Female Participants)

    Vaginal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points. Evaluable Tissue-Fluid and PK Parameter Population (Oral plus IM) comprised of all participants who underwent sampling following oral dose in treatment period 1 and IM injection in treatment period 2 and have both evaluable PK and evaluable tissues-fluid parameters estimated in vaginal tissue/cervical tissue/cervicovaginal fluid/rectal tissue/rectal fluid.

    Measured: One sample on Day 3 and Week 8 post-dose

  3. Cabotegravir Concentration in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  4. Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  5. Cabotegravir Concentration in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  6. Cabotegravir Concentration in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure cabotegravir concentration following a single 600 mg IM dose at indicated time-points.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

Secondary outcomes (105)

  1. Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

    Vaginal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in blood plasma is presented.

    Measured: One sample on Day 3 and Week 8 post-dose

  2. Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in blood plasma is presented.

    Measured: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

  3. Ratio of Cabotegravir Concentration in Cervicovaginal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration (Female Participants)

    Cervicovaginal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervicovaginal fluid to cabotegravir concentration in blood plasma is presented.

    Measured: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

  4. Ratio of Cabotegravir Concentration in Cervical Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervical tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in cervical tissue to cabotegravir concentration in cervicovaginal fluid is presented.

    Measured: One sample on Day 3, 8, Weeks 4, 8 and 12

  5. Ratio of Cabotegravir Concentration in Vaginal Tissue to Cabotegravir Concentration in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Vaginal tissue and cervicovaginal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in vaginal tissue to cabotegravir concentration in cervicovaginal fluid is presented.

    Measured: One sample on Day 3 and Week 8 post-dose

  6. Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Blood Plasma Following IM Administration

    Rectal tissue and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in blood plasma is presented.

    Measured: One sample on Day 3, 8, Weeks 4, 8 and 12 post-dose

  7. Ratio of Cabotegravir Concentration in Rectal Fluid to Cabotegravir Concentration in Blood Plasma Following IM Administration

    Rectal fluid and blood samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal fluid to cabotegravir concentration in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  8. Ratio of Cabotegravir Concentration in Rectal Tissue to Cabotegravir Concentration in Rectal Fluid Following IM Administration

    Rectal tissue and rectal fluid samples were collected to measure cabotegravir concentration following cabotegravir IM dose at indicated time-points. Data for ratio of cabotegravir concentration in rectal tissue to cabotegravir concentration in rectal fluid is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  9. Maximum Observed Concentration (Cmax) of Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

  10. Cmax of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  11. Cmax of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  12. Cmax of Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  13. Cmax of Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure Cmax at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  14. Area Under the Concentration Time Curve From Time Zero to Last Quantifiable Time Point (AUC[0-last]) for Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, One sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

  15. AUC(0-last) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  16. AUC(0-last) of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  17. AUC(0-last) for Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  18. AUC(0-last) for Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure AUC(0-last) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  19. Area Under the Concentration Time Curve From Time Zero to Infinity (AUC[0-inf]) for Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

  20. AUC(0-inf) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  21. AUC(0-inf) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  22. AUC(0-inf) for Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  23. AUC(0-inf) for Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure AUC(0-inf) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  24. Area Under the Concentration Time Curve From Time Zero to Week (WK) 4 (AUC[0-WK4]) for Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8 and Week 4 post-dose

  25. AUC(0-WK4) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  26. AUC(0-WK4) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  27. AUC(0-WK4) for Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  28. AUC(0-WK4) for Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure AUC(0-WK4) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  29. Area Under the Concentration Time Curve From Time Zero to Week 8 (AUC[0-WK8]) for Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4 and 8 post-dose

  30. AUC(0-WK8) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  31. AUC(0-WK8) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  32. AUC(0-WK8) for Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  33. AUC(0-WK8) for Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure AUC(0-WK8) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  34. Area Under the Concentration Time Curve From Time Zero to Week 12 (AUC[0-WK12]) for Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8 and 12 post-dose

  35. AUC(0-WK12) for Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  36. AUC(0-WK12) for Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  37. AUC(0-WK12) for Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  38. AUC(0-WK12) for Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure AUC(0-WK12) at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  39. Apparent Terminal Phase Half-life (t1/2) of Cabotegravir in Blood Plasma Following IM Administration

    Blood samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: Day 1: Pre-dose, 4 hours, one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52 post-dose

  40. t1/2 of Cabotegravir in Cervical Tissue Following IM Administration (Female Participants)

    Cervical tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  41. t1/2 of Cabotegravir in Cervicovaginal Fluid Following IM Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  42. t1/2 of Cabotegravir in Rectal Tissue Following IM Administration

    Rectal tissue samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  43. t1/2 of Cabotegravir in Rectal Fluid Following IM Administration

    Rectal fluid samples were collected to measure t1/2 at indicated time-points. Pharmacokinetic parameters were determined using standard non-compartmental methods.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  44. Ratio of AUC(0-last) in Cervical Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervical tissue to AUC(0-last) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  45. Ratio of AUC(0-last) in Rectal Tissue to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal tissue and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal tissue to AUC(0-last) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  46. Ratio of AUC(0-inf) in Cervical Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervical tissue to AUC(0-inf) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  47. Ratio of AUC(0-inf) in Rectal Tissue to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal tissue and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal tissue to AUC(0-inf) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  48. Ratio of AUC(0-Wk4) in Cervical Tissue to AUC(0-Wk4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervical tissue to AUC(0-WK4) in blood plasma is presented.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  49. Ratio of AUC(0-Wk 4) in Rectal Tissue to AUC(0-Wk 4) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal tissue and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal tissue to AUC(0-WK4) in blood plasma is presented.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  50. Ratio of AUC(0-WK8) in Cervical Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervical tissue to AUC(0-WK8) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  51. Ratio of AUC(0-WK8) in Rectal Tissue to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal tissue and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal tissue to AUC(0-WK8) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  52. Ratio of AUC(0-WK12) in Cervical Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervical tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervical tissue to AUC(0-WK12) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  53. Ratio of AUC(0-WK12) in Rectal Tissue to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal tissue and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal tissue to AUC(0-WK12) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  54. Ratio of AUC(0-last) in Cervicovaginal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration-female Participants

    Cervicovaginal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in cervicovaginal fluid to AUC(0-last) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  55. Ratio of AUC(0-last) in Rectal Fluid to AUC(0-last) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal fluid and blood samples were collected to measure AUC(0-last) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-last) in rectal fluid to AUC(0-last) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  56. Ratio of AUC(0-inf) in Cervicovaginal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervicovaginal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in cervicovaginal fluid to AUC(0-inf) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  57. Ratio of AUC(0-inf) in Rectal Fluid to AUC(0-inf) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal fluid and blood samples were collected to measure AUC(0-inf) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-inf) in rectal fluid to AUC(0-inf) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  58. Ratio of AUC(0-WK4) in Cervicovaginal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in cervicovaginal fluid to AUC(0-WK4) in blood plasma is presented.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  59. Ratio of AUC(0-WK4) in Rectal Fluid to AUC(0-WK4) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal fluid and blood samples were collected to measure AUC(0-WK4) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK4) in rectal fluid to AUC(0-WK4) in blood plasma is presented.

    Measured: One sample on Days 3, 8 and Week 4 post-dose

  60. Ratio of AUC(0-WK8) in Cervicovaginal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in cervicovaginal fluid to AUC(0-WK8) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  61. Ratio of AUC(0-WK8) in Rectal Fluid to AUC(0-WK8) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal fluid and blood samples were collected to measure AUC(0-WK8) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK8) in rectal fluid to AUC(0-WK8) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4 and 8 post-dose

  62. Ratio of AUC(0-WK12) in Cervicovaginal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration (Female Participants)

    Cervicovaginal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in cervicovaginal fluid to AUC(0-WK12) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  63. Ratio of AUC(0-WK12) in Rectal Fluid to AUC(0-WK12) in Blood Plasma for Cabotegravir Following IM Administration

    Rectal fluid and blood samples were collected to measure AUC(0-WK12) following cabotegravir IM dose at indicated time-points. Data for ratio of AUC(0-WK12) in rectal fluid to AUC(0-WK12) in blood plasma is presented.

    Measured: One sample on Days 3, 8, Weeks 4, 8 and 12 post-dose

  64. Cabotegravir Concentration in Vaginal Tissue Following Oral Administration (Female Participants)

    Vaginal tissue samples were collected to measure cabotegravir concentration in vaginal tissue following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  65. Cabotegravir Concentration in Cervical Tissue Following Oral Administration (Female Participants)

    Cervical tissue samples were collected to measure cabotegravir concentration in cervical tissue following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  66. Cabotegravir Concentration in Cervicovaginal Fluid Following Oral Administration (Female Participants)

    Cervicovaginal fluid samples were collected to measure cabotegravir concentration in cervicovaginal fluid following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  67. Cabotegravir Concentration in Rectal Tissue Following Oral Administration

    Rectal tissue samples were collected to measure cabotegravir concentration in rectal tissue following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  68. Cabotegravir Concentration in Rectal Fluid Following Oral Administration

    Rectal fluid samples were collected to measure cabotegravir concentration in rectal fluid following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  69. Cabotegravir Concentration in Blood Plasma Following Oral Administration

    Blood samples were collected to measure cabotegravir concentration in blood plasma following oral 30 mg dose at indicated time-points.

    Measured: 24 hours post-dose on Day 28

  70. Number of Participants With Any Non-serious Adverse Event (Non-SAE) and Serious Adverse Events (SAE) Following Oral Administration of Cabotegravir

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment, associated with liver injury and impaired liver function was categorized as SAE. Number of participants with any non-SAE and SAE are presented.

    Measured: Up to Day 29

  71. Number of Participants With Any Non-SAE and SAE Following IM Administration of Cabotegravir

    An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly or birth defect or any other situation according to medical or scientific judgment, associated with liver injury and impaired liver function was categorized as SAE. Number of participants with any non-SAE and SAE are presented.

    Measured: Up to Week 52

  72. Change From Baseline in Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP) and Aspartate Amino Transferase (AST) at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  73. Change From Baseline in ALT, ALP and AST at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; ALT, ALP and AST following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  74. Change From Baseline in Creatine Kinase at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  75. Change From Baseline in Creatine Kinase at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of clinical chemistry parameter; creatine kinase following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 8 and 12

  76. Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  77. Change From Baseline in Creatinine, Direct Bilirubin and Total Bilirubin at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; creatinine, direct bilirubin and total bilirubin following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  78. Change From Baseline in Albumin and Total Protein at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  79. Change From Baseline in Albumin and Total Protein at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; albumin and total protein following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  80. Change From Baseline in Calcium, Glucose, Potassium, Sodium and Urea Enzymatic Colorimetry at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and urea enzymatic colorimetry (UEC) following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  81. Change From Baseline in Calcium, Glucose, Potassium, Sodium and UEC at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of clinical chemistry parameters; calcium, glucose, potassium, sodium and UEC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  82. Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  83. Change From Baseline in Basophil Count, Eosinophil Count, Lymphocyte Count and Monocyte Count at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameters; basophil count, eosinophil count, lymphocyte count and monocyte count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4 and 8

  84. Change From Baseline in Total Neutrophil Count at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameter; total neutrophils count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  85. Change From Baseline in Total Neutrophil Count at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameters; total neutrophil count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  86. Change From Baseline in Platelet Count and White Blood Cell (WBC) Count at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  87. Change From Baseline in Platelet Count and WBC Count at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameters; platelet count and WBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  88. Change From Baseline in Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC) at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  89. Change From Baseline in Hemoglobin and MCHC at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameters; hemoglobin and MCHC following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  90. Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  91. Change From Baseline in MCH at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameter; MCH following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  92. Change From Baseline in Mean Corpuscle Volume (MCV) at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  93. Change From Baseline in MCV at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameter; MCV following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  94. Change From Baseline in Hematocrit at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  95. Change From Baseline in Hematocrit at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameter; hematocrit following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  96. Change From Baseline in Red Blood Cell (RBC) Count at Indicated Time Points (Oral Dose)

    Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir oral dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 1 (post-dose), 14 and 29

  97. Change From Baseline in RBC Count at Indicated Time Points (IM Dose)

    Blood samples were collected for the assessment of hematology parameter; RBC count following cabotegravir IM dose at indicated time-points. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Weeks 4, 8 and 12

  98. Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Indicated Time Points (Oral Dose)

    SBP and DBP were measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  99. Change From Baseline in SBP and DBP at Indicated Time Points (IM Dose)

    SBP and DBP were measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

  100. Change From Baseline in Pulse Rate at Indicated Time Points (Oral Dose)

    Pulse rate was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  101. Change From Baseline in Pulse Rate at Indicated Time Points (IM Dose)

    Pulse rate was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

  102. Change From Baseline in Body Temperature at Indicated Time Points (Oral Dose)

    Body temperature was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 14 and 29

  103. Change From Baseline in Body Temperature at Indicated Time Points (IM Dose)

    Body temperature was measured in a semi-supine position after approximately 10 minutes rest. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value. Baseline was defined as the latest pre-dose (Day 1) assessment with a non-missing value, including those from unscheduled visits.

    Measured: Baseline (Day 1, Pre-dose), Days 3, 5, 8, Weeks 4, 8, 12, 24, 36, and 52

  104. Number of Participants With Abnormal Urinalysis Parameters Following Oral Administration of Cabotegravir

    Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.

    Measured: Up to Day 29

  105. Number of Participants With Abnormal Urinalysis Parameters Following IM Administration of Cabotegravir

    Urinalysis included assessment of pH, glucose, protein, blood and ketones by dipstick method. This analysis was not planned and data was not collected and not captured in the database.

    Measured: Up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2015 (estimated)
  2. Study start27 Feb 2017
  3. Primary completion25 Jul 2019
  4. Study completion25 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02478463
Sponsor's protocol ID
201767
Status last verified
Jun 2020
First submitted
18 Jun 2015
Last updated
22 Jun 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cabotegravir tablet 30 mg once daily for 28 days. and Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1. in people with Infection, Human Immunodeficiency Virus and HIV Infections, run by ViiV Healthcare at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cabotegravir Concentration in Blood Plasma Following IM Administration (time frame: Day 1: Pre-dose and 4 hours; one sample on Days 3, 5, 8, Weeks 4, 8, 12, 24, 36 and 52 post-dose). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02478463.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.

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