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HIV InfectionsPhase 2NCT06741397

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

A Phase 2 study testing CAB LA and New formulation of CAB LA in people with HIV Infections, run by ViiV Healthcare at 27 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition. Read more about this study

Who is it for?
Ages 16 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections
What is being tested?
CAB LA and New formulation of CAB LA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
27 sitesin 2 countries
Study dates
20 Dec 2024to 30 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 16 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • At the time of obtaining informed consent, adolescent and adult participants weighing at least 35 kg.
  • Participants must have a nonreactive HIV test at Screening (rapid test, nonrapid HIV immunoassay, and HIV RNA) and enrollment (a rapid test, nonrapid HIV immunoassay, and HIV RNA).
  • Participants who are at risk of acquiring HIV, defined as having had anal or vaginal sex in the past 6 months.
  • Participants who are overtly healthy as determined by medical evaluation by a responsible and experienced physician, including medical history, physical examination, laboratory tests and cardiac monitoring at the time of screening.
  • No alcohol or substance use that, in the opinion of the study investigator and medical monitor, would interfere with the conduct of the study (e.g., provided by self-report, or found upon medical history and examination or in available medical records).
  • Participants who have received oral PrEP are eligible, but they must discontinue oral PrEP within 10 days of Day 1 visit.
  • Male or female at birth, (transgender individuals are not excluded). Contraceptive use should align with local regulations. Participants assigned female at birth must not be pregnant or breastfeeding and must either not be of childbearing potential (POCBP) or use highly effective contraception. A POCBP must have a negative pregnancy test within 30 days before dosing.
  • Participants must be >=16 years old, of legal age to consent to sexual intercourse, and capable of giving written informed consent. Adolescents must provide written informed assent/consent and/or obtain parental/guardian consent if not of legal age, as per site SOPs and IRB/EC policies.

Who cannot join

  • One or more reactive or positive HIV test results at Screening or Enrollment, even if HIV infection was not confirmed.
  • Participants who are breastfeeding or plan to become pregnant or breastfeed during the study.
  • Alanine aminotransferase (ALT) >=3 times the upper limit of normal (ULN).
  • Evidence of active Hepatitis B virus (HBV) infection.
  • Participants positive for HBsAg or HBV DNA are excluded.
  • Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded.
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  • Unstable liver disease, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
  • History of clinically relevant hepatitis within last 6 months.
  • Known history of liver cirrhosis with or without viral hepatitis co-infection.
  • Participants with Hepatitis C virus (HCV) co-infection will be allowed entry into this study if:
  • Liver enzymes meet entry criteria.
  • HCV Disease has undergone appropriate work-up, and is not advanced, and will not require treatment prior to the primary endpoint (e.g., Month 13).
  • In the event that recent biopsy or imaging data is not available or inconclusive, the Fibrosis 4 (Fib-4) score will be used to verify eligibility:
  • Fib-4 score greater than (>) 3.25 is exclusionary. ii. Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 score Formula: (Age x AST) / (Platelets x (sqr [ ALT]) It is approved by the Medical Monitor.
  • Estimated glomerular filtration rate of <30 mL/min/1.73 m^2 via CKD-EPIcr_R (2021) method.
  • Any acute laboratory abnormality at Screening, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound.
  • Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 [triglycerides or lipid abnormalities].
  • Participants determined by the Investigator to have a high risk of seizures, A participant with a prior history of seizure 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.
  • Participant is currently participating in or has participated in a study with a compound or device that is not commercially available within 30 days of signing informed consent, unless permission from the Medical Monitor is granted.
  • Presence of any history of allergy/sensitivity to any of the study drug.
  • Inflammatory skin conditions that compromise the safety of IM injections, per the discretion of the investigator.
  • Participant has an implant/enhancement (including fillers) at the area of proposed injection (e.g., gluteus medius); or tattoo or other dermatological condition overlying the area for IM (e.g., gluteus medius) or any other area which may significantly interfere with interpretation of injection site reactions.
  • Current or anticipated need for chronic anti-coagulants or active coagulopathy (primary or iatrogenic) which would contraindicate IM injection.
  • Ongoing or clinically relevant pancreatitis.
  • Clinically significant cardiovascular disease or history of clinically significant cardiovascular disease.
  • All participants will be screened for STIs (e.g., chlamydia, gonorrhea, trichomoniasis, syphilis). Participants with untreated infections are excluded. Participants may be rescreened at least 24 hours after completion of STI treatment.
  • History or presence of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
  • Ongoing uncontrolled malignancy is excluded, whereas participants who have controlled localized malignancies may be included on agreement between the investigator and the Medical Monitor.
  • Participants who in the investigator's judgment, poses a significant suicidality risk.
  • Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator or the medical monitor, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
  • Any condition which, in the opinion of the Investigator or the medical monitor, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive IM medication.
  • Co-enrollment in any other interventional research study or other concurrent studies which may have interfered with this study (as provided by self-report or other available documentation). Exceptions for non-interventional studies may be made if appropriate after consultation with the Medical Monitor.
  • Participants receiving any protocol-prohibited medication and who are unwilling or unable to switch to an alternate medication.
  • Use of antiretroviral therapy (ART) for Postexposure Prophylaxis within the 90 days prior to Day 1.
  • Use of CAB LA for PrEP at any time prior to Screening.
  • Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP.
  • Anticipated need for HCV therapy with interferon or any drugs that have potential for adverse drug:drug interactions with study treatment throughout the entire study period.
  • Treatment with an HIV-1 preventive vaccine within 90 days of Screening.
  • Participant is unlikely to adhere to the study procedures, keep appointments, is planning to relocate during the study, or remain on study through to its conclusion.
  • Participants who are considered high-risk, meeting at least one of the following criteria:
  • Participant who has exchanged condomless sex for goods or money within the past 12 months prior to Screening.
  • Participant who has used recreational intravenous drugs within the past 12 months prior to Screening.
  • Participant who has participated in Chemsex practice (such as the use of cocaine, crack cocaine, methamphetamine, ketamine, 3,4-methlenedioxy-methamphetamine, GHB, mephedrone or prescription drugs apart from those prescribed by a licensed provider) within the past 6 months prior to Screening.
  • Participant with any STI in the last 6 months also reporting any partners for condomless sex.
  • Participant who has condomless sex with a serodiscordant partner who has a detectable viral load or is not on ART.
  • Participant with any other behavior assessed by the investigator as high-risk sexual behavior.
  • Participant has in the last 14 days prior to Screening presented with signs and symptoms, which, in the opinion of the investigator, are suggestive of acute HIV infection. Participants may only be enrolled if clinical suspicion of HIV is ruled out with non-reactive results.
  • Participant becomes a ward of state (e.g., child in care).

Trial locations and contacts

27 sites in 2 countries.

27 sites in 2 countries

United States25 sites

  • GSK Investigational Site

    Berkley, Michigan, 48072

  • GSK Investigational Site

    Birmingham, Alabama, 35222

  • GSK Investigational Site

    Chicago, Illinois, 60612-7230

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Dallas, Texas, 75246-2004

  • GSK Investigational Site

    Doral, Florida, 33172-2513

  • GSK Investigational Site

    Fort Worth, Texas, 76104

  • GSK Investigational Site

    Ft. Pierce, Florida, 34982-7148

  • GSK Investigational Site

    Greensboro, North Carolina, 27401-1209

  • GSK Investigational Site

    Hawthorne, New York, 10532-2140

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Las Vegas, Nevada, 89119

  • GSK Investigational Site

    Los Angeles, California, 90027

  • GSK Investigational Site

    Los Angeles, California, 90035

  • GSK Investigational Site

    Los Angeles, California, 90036

  • GSK Investigational Site

    Los Angeles, California, 90069

  • GSK Investigational Site

    New Orleans, Louisiana, 70112

  • GSK Investigational Site

    New York, New York, 10029

  • GSK Investigational Site

    Orlando, Florida, 32803-1851

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Springfield, Massachusetts, 01105

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

Other trials in United States

Puerto Rico2 sites

  • GSK Investigational Site

    San Juan, 00909

  • GSK Investigational Site

    San Juan, 909

Other trials in Puerto Rico

About this study

Official title: A Phase 2b Single Arm, Repeat Dose Study to Evaluate the Pharmacokinetic Profile, Safety, and Tolerability of A New Formulation of Cabotegravir LA Injected Intramuscularly Q4M in Adolescent and Adult Participants at Risk of HIV Acquisition

This study will evaluate the pharmacokinetics (PK), safety, and tolerability of a new formulation of Cabotegravir (CAB) dosed every 4-months (Q4M) for pre-exposure prophylaxis (PrEP) in participants at risk of HIV-1 acquisition.

Conditions
HIV Infections
Being tested
CAB LA, New formulation of CAB LA
Keywords
Cabotegravir (CAB), New formulation of CAB LA, CAB LA, HIV, 4-month dosing interval (Q4M), Safety
Medical subject headings
HIV Infections

What participants receive

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

  • CAB LADrug

    Injections administered IM gluteal.

  • New formulation of CAB LADrug

    Injections administered IM gluteal.

Study groups in NCT06741397
Study groupRoleWhat they receive
CAB GroupExperimentalParticipants receive lead-in injections comprising cabotegravir LA during month one and injections of a new formulation of CAB LA at Month 3, Month 5 and every 4 months thereafter to Month 29.
Receives: Drug: CAB LA; Drug: New formulation of CAB LA

What is being measured

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

  1. CAB trough concentrations for target of 1.05 microgram per milliliter (μg/mL) for men and 1.39 μg/mL for women

    CAB trough concentrations are evaluated at or above the target of 1.05 μg/mL for men and 1.39 μg/mL for women, once steady state has been achieved, but no earlier than Month 13 of the study.

    Measured: From Month 13 to Month 25

Secondary outcomes (11)

  1. CAB trough concentrations for target of 0.672 μg/mL for men and 0.683 μg/mL for women

    CAB trough concentrations are evaluated at or above the target of 0.672 μg/mL for men and 0.683 μg/mL for women.

    Measured: At Month 1

  2. CAB trough concentrations for target of 1.05 μg/mL for men and 1.39 μg/mL for women following loading dose

    CAB trough concentrations are evaluated at or above the target of 1.05 μg/mL for men and 1.39 μg/mL for women.

    Measured: From Month 3 to Month 33

  3. CAB plasma concentrations

    Blood samples are collected by visit.

    Measured: At Day 1, Day 1+1Week (W), Month (M) 1, M1+1W, M2, M3, M3+1W, M4, M5, M5+1W, M6, M7, M8, M9, M9+1W, M10, M11, M13, M13+1W, M17, M17+1W, M21, M25, M29, and M33

  4. CAB trough concentrations for target of 4x PA-IC90

    CAB trough concentrations are evaluated at or above the target of 4 times (4x) PA-IC90. PA-IC90 is defined as protein-adjusted concentration at which 90% inhibition of viral replication is achieved.

    Measured: At Months 1, 3, 5, 9, 13, 17, 21, 25, 29, and 33

  5. Percentage of participants with confirmed incident HIV infections

    Measured: Up to Month 33

  6. Percentage of participants with Study Medication Satisfaction Questionnaire Status version (SMSQs) results

    SMSQs is a self-completion measure which is evaluating 11-items (i.e., satisfaction, side effects, demands, convenience, flexibility, understanding, lifestyle, recommend, continue, easy or difficult, discomfort or pain). SMSQs is self-administered at each planned study visit and prior to the study drug administration.

    Measured: From Month 1 up to Month 33

  7. Percentage of participants with Adverse events (AEs)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

    Measured: Up to Month 33

  8. Percentage of participants with AEs by severity

    Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

    Measured: Up to Month 33

  9. Percentage of participants with laboratory abnormalities

    Measured: Up to Month 33

  10. Percentage of participants with laboratory abnormalities by severity

    Severity is graded according to the DAIDS grading criteria, where Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening.

    Measured: Up to Month 33

  11. Percentage of participants with changes in laboratory parameters

    Measured: Up to Month 33

Timeline

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

  1. First posted19 Dec 2024
  2. Study start20 Dec 2024
  3. Primary completion9 Sep 2026
  4. Study completion30 Aug 2029 (estimated)

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 2
Primary purpose
Other
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06741397
Sponsor's protocol ID
219230
Other IDs
2024-000061-24
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Study sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.viiv-studyregister.com/documents/About\_ViiV\_Patient\_Level\_Data\_Sharing\_Final\_25Sep2023.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CAB LA and New formulation of CAB LA in people with HIV Infections, run by ViiV Healthcare at 27 sites in 2 countries.

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 8 inclusion and 48 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

CAB trough concentrations for target of 1.05 microgram per milliliter (μg/mL) for men and 1.39 μg/mL for women (time frame: From Month 13 to Month 25). 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 NCT06741397.

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 5 Oct 2026.

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