Infection, Human Immunodeficiency VirusPhase 1NCT02354937

Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment

A Phase 1 study testing GSK1265744 30 mg 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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Infection, Human Immunodeficiency Virus, HIV Infections
What is being tested?: GSK1265744 30 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 2 sitesUnited States
Study dates: 13 Jul 2015to 1 Nov 2016
Phase: Phase 1
Are there results?: None posted in the registry

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For Renally Impaired Subjects (Cohort 1)
Between 18 and 70 years of age inclusive, at the time of signing the informed consent.
Severe renal impairment, defined as individuals with a creatinine clearance of < 30 milliliter (mL)/minute (min) as determined by a 24-hour urine creatinine clearance done at screening.
Renally impaired subjects must have clinical laboratory test results that are considered clinically stable in the opinion of the principal investigator. Subjects with laboratory parameters outside the reference range may be included if, in the opinion of the investigator and medical monitor, these findings will not interfere with the study or introduce additional safety risk to the subject.
Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 19 - 38 kg/ meter (m)^2 (inclusive)
Male or female A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test), not lactating. Women of child-bearing potential must be willing to practice acceptable methods of birth control. Pre-menopausal females defined as 12 months of spontaneous amenorrhea with one of the following: Documented tubal ligation, hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Bilateral Oophorectomy. Postmenopausal

Show all 16Show fewer

Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
For Healthy Subjects (Cohort 2)
Healthy control subjects will be matched for age +/-10 years to subjects in the renal impairment cohort but must also remain in the age range:
Between 18 and 70 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.
Healthy subjects are defined as individuals with a creatinine clearance >= 90 mL/min as determined by a 24-hour urine creatinine clearance done at screening.
Healthy control subjects will be matched for BMI +/- 25% to subjects in the renal impairment cohort but must also remain in the range of:
Body weight >=50 kg and BMI within the range 19 - 38 kg/m^2 (inclusive)
Male or female A female subject is eligible to participate if she is not pregnant (as confirmed by a negative serum hCG test), not lactating. Women of child-bearing potential must be willing to practice acceptable methods of birth control. Pre-menopausal females defined as 12 months of spontaneous amenorrhea with one of the following: Documented tubal ligation, hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Bilateral Oophorectomy. Postmenopausal
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

For Renally Impaired Subjects (Cohort 1)
Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease (including acute or chronic hepatitis B and C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT Interval (QTc) > 480 millisecond (msec)
NOTES:
The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF) machine-read or manually over-read.

Show all 65Show fewer

For purposes of data analysis, QT interval corrected for heart rate according to Bazette's formula (QTcB), QTcF, or a composite of available values of QTc will be used as specified in the Reporting and Analysis Plan (RAP).
Systolic blood pressure outside the range of 90-160mmHg, or diastolic blood pressure outside the range of 45-95 millimeter of mercury (mmHg), or heart rate outside the range of 50-100 beats per minute (bpm) for female subjects or 45-100 bpm for male subjects in the presence (or absence) of stabilized antihypertensive treatment.
Evidence of previous myocardial infarction in the past 12 months or any clinically significant active cardiovascular disease that, in the opinion of the investigator, could interfere with the safety of the subject.
Any clinically significant conduction abnormality (not including left or right complete bundle branch block) such as atrioventricular (AV) block [Mobitz type 2 second degree or higher AV block], Wolf Parkinson White [WPW] syndrome or other aberrant pathways.
Sinus Pauses >3 seconds.
Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety of the individual subject.
Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
Signs of active infection that in the opinion of the investigator would interfere with the completion of study procedures or the safety of the subject.
Fluctuating or rapidly deteriorating renal function, or currently receiving hemodialysis, peritoneal dialysis, or any other renal replacement therapy or other medical procedure that serves as a surrogate for renal function. Assessment of the stability of the subject's renal function will be determined by the investigator.
History of renal transplant.
History of inflammatory bowel disease.
History of cholecystectomy or other gastrointestinal surgery (except appendectomy more than three months prior to study).
History of peptic ulceration or pancreatitis within the preceding 6 months of screening.
Any other medical condition (except renal impairment) which, in the judgment of the investigator and medical monitor, could jeopardize the integrity of the data derived from that subject or the safety of the subject. This includes but is not limited to any pre-existing condition that interferes with normal gastrointestinal anatomy or motility that could interfere with the absorption, metabolism, and/or excretion of the study drug.
The use of any concurrent prohibited medications
Subjects with a change in dose regimen of medically required medication within the 2 weeks prior to dosing.
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 grams (g) of alcohol: 12 ounces (360 millilitre [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
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. 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.
A pre-study screen positive for alcohol, cocaine, amphetamines, phencyclidine (PCP), and/or barbiturates. A positive drug screen is permitted if it is due to a prescribed medication, provided that medication is not a Prohibited Medication.
A positive test for HIV antibody.
A creatinine clearance <15 mL/min as determined by 24-hour urine collection.
A clinically significant elevation in serum potassium at screening, that in the opinion of the investigator and GSK Medical Monitor will interfere with the study or introduce additional safety risk to the subject.
A serum sodium level =<125 milliequivalent (mEq) /liter (L) at screening
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
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).
Unwillingness or inability to follow the procedures outlined in the protocol.
For Healthy Subjects (Cohort 2)
ALT and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease (including acute or chronic Hepatitis B and C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
QTc > 450 msec
NOTES:
The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF) machine-read or manually over-read.
For purposes of data analysis, QTcB, QTcF, or a composite of available values of QTc will be used as specified in the RAP.
Systolic blood pressure outside the range of 90-145 mmHg, or diastolic blood pressure outside the range of 45-95mmHg or heart rate outside the range of 50-100 bpm for female subjects or 45-100 bpm for male subjects.
Evidence of previous myocardial infarction or any clinically significant active cardiovascular disease that, in the opinion of the investigator, could interfere with the safety of the subject.
Any clinically significant conduction abnormality (not including left or right complete bundle branch block) such as AV block [Mobitz type 2 second degree or higher AV block], Wolf Parkinson White [WPW] syndrome or other aberrant pathways.
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 or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
Signs of active infection that in the opinion of the investigator would interfere with the completion of study procedures or the safety of the subject.
Fluctuating or deteriorating renal function or creatinine clearance (CLCR) < 90 mL/min (determined by 24-hour urine collection) at screening. Assessment of the stability of the subject's renal function will be determined by the investigator.
Subjects with a pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, that could interfere with the absorption, metabolism, and/or excretion of the study drugs.
History of inflammatory bowel disease.
History of cholecystectomy or other gastrointestinal surgery (except appendectomy more than three months prior to study).
History of peptic ulceration or pancreatitis within the preceding 6 months of screening.
The use of any concurrent prohibited medications.
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 g of alcohol: 12 ounces (360 mL) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
A history of regular use of tobacco- or nicotine-containing products within 30 days prior to screening.
Inability or unwillingness to comply with lifestyle and/or dietary restrictions
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. 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.
Presence of hepatitis B surface antigen (or positive hepatitis B core antibody with negative hepatitis B surface antibody) or positive hepatitis C antibody test result at any time prior to first dose of study treatment.
A pre-study screen positive for alcohol, cocaine, amphetamines, PCP, and/or barbiturates.
A positive test for HIV antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 56 days.
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).
Unwillingness or inability to follow the procedures outlined in the protocol.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

GSK Investigational Site
Lakewood, Colorado, 80228
GSK Investigational Site
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Phase I, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 in Subjects With Severe Renal Impairment and Healthy Matched Control Subjects

GSK1265744 (744) is an integrase strand transfer inhibitor (INSTI) currently in development for both the treatment and prevention of human immunodeficiency virus (HIV) infection. Renal elimination of unchanged 744 is extremely low, with no parent 744 detected in the urine after a single 30 mg radiolabeled dose. Despite the minimal contribution of renal clearance on overall 744 elimination, renal impairment may potentially inhibit some pathways of hepatic and gut drug metabolism and transport, and as a result may impact 744 pharmacokinetics. The current Food and Drug Administration (FDA) draft guidance for renal impairment studies suggests that a pharmacokinetic (PK) study in patients with renal impairment be conducted even for those drugs primarily metabolized or secreted in bile.

The study will be comprised of two cohorts (severe renal impairment and normal renal function) of 8 subjects each. Upon enrolment, each subject will be admitted to the study center and undergo serial PK sampling following a single dose of oral 744 30 milligrams (mg). Subjects will return to the clinic for follow-up evaluations 10-14 days after the 744 30 mg dose.

Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Being tested: GSK1265744 30 mg
Keywords: Pharmacokinetics, GSK1265744, Severe Renal Impairment
Medical subject headings: Infections, Acquired Immunodeficiency Syndrome, HIV Infections, Renal Insufficiency

What participants receive

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

GSK1265744 30 mgDrug
White to almost white coated oval tablets with unit dose strength of 30 mg for oral administrations.

Study groups in NCT02354937
Study group	Role	What they receive
Subjects with renal impairment	Experimental	Subjects with severe renal impairment will receive single oral dose of 744 30 mg Receives: Drug: GSK1265744 30 mg
Subjects with normal renal function	Active comparator	Subjects with normal renal function will receive single oral dose of 744 30 mg Receives: Drug: GSK1265744 30 mg

What is being measured

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

Composite of PK parameters evaluated by measurement of AUC (0-infinity) and Cmax following single oral dose.
To compare effect of severe renal impairment on PK parameters for 744 assessed by Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) and Maximum observed concentration (Cmax)
Measured: Samples will be collected at pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.

Secondary outcomes (6)

Unbound concentration and unbound fraction in plasma of GSK1265744 at 2 and 24 hours post dose
To evaluate impact of severe renal impairment on the plasma concentration of 744 assessed by measuring unbound concentration and unbound fraction in plasma of 744
Measured: Samples will be collected at 2 and 24 hours post dose.
Composite of PK parameters for GSK1265744 evaluated by measurement of Plasma AUC(0-t), %AUCex, C24, t1/2, CL/F, tlag, tmax and Vz/F following a single oral dose
To evaluate composite of PK parameters for 744 assessed by Area under the concentration-time curve from time zero (pre-dose) to the time of the last quantifiable concentration (AUC[0-t]), Percentage of AUC(0- infinity) obtained by extrapolation (%AUCex), Concentration observed 24-hours post dose (C24), Apparent terminal phase half-life (t1/2), Lag time before observation of drug concentrations in sampled matrix (tlag), Time of occurrence of Cmax (tmax), Apparent clearance following oral dosing (CL/F), apparent terminal phase volume of distribution (Vz/F)
Measured: Samples will be collected at pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
Number of participants with adverse events as measure of safety and tolerability
To evaluate Safety and tolerability of single oral dose of 744 assessed by clinical safety data from number of participants with adverse event. Reporting of adverse event from the start of Study Treatment and until the final follow-up visit. Intensity of AEs will be categorized as mild, moderate or severe.
Measured: Day -1 to Day 15
Safety and tolerability of single oral dose of 744 assessed by clinical laboratory tests
To evaluate Safety and tolerability of single oral dose of 744 assessed by safety laboratory tests including Hematology, clinical chemistry, urinalysis and additional parameters
Measured: 14 Days
Safety and tolerability of single oral dose of 744 assessed by12-Lead electrocardiogram
To evaluate Safety and tolerability of single oral dose of 744 assessed by12-Lead Electrocardiogram (ECG).
Measured: 2 Days
Safety and tolerability of single oral dose of 744 assessed by vital signs
To evaluate Safety and tolerability of single oral dose of 744 assessed by vital signs. It will include temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate.
Measured: 14 Days

Timeline

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

13 Jul 20151 Nov 2016

First posted3 Feb 2015 (estimated)
Study start13 Jul 2015
Primary completion1 Nov 2016
Study completion1 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infection, Human Immunodeficiency VirusStudies of the same condition, open and under way.
More trials run by ViiV HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02354937
Sponsor's protocol ID: 201480
Status last verified: Aug 2020
First submitted: 29 Jan 2015
Last updated: 28 Aug 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Parasrampuria R, Ford SL, Lou Y, Fu C, Bakshi KK, Tenorio AR, Trezza C, Spreen WR, Patel P. A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants. Clin Pharmacol Drug Dev. 2019 Jul;8(5):674-681. doi: 10.1002/cpdd.664. Epub 2019 Feb 27.
PubMed 30809978

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetics and Safety of GSK1265744 in Subjects With Severe Renal Impairment and Healthy Matched Control Subjects
ClinicalTrials.gov ID: NCT02354937
Acronym / sponsor ID: 201480
Conditions: Infection, Human Immunodeficiency Virus, HIV Infections
Keywords: Pharmacokinetics, GSK1265744, Severe Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: ViiV HealthcareIndustry (pharma, biotech, devices)
Study start: 13 Jul 2015 (actual)
Primary completion: 1 Nov 2016 (actual)
Study completion: 1 Nov 2016 (actual)
First posted: 3 Feb 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Subjects with renal impairment	Experimental	Drug: GSK1265744 30 mgSubjects with severe renal impairment will receive single oral dose of 744 30 mg
Subjects with normal renal function	Active comparator	Drug: GSK1265744 30 mgSubjects with normal renal function will receive single oral dose of 744 30 mg

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

For Renally Impaired Subjects (Cohort 1)
Between 18 and 70 years of age inclusive, at the time of signing the informed consent.
Severe renal impairment, defined as individuals with a creatinine clearance of < 30 milliliter (mL)/minute (min) as determined by a 24-hour urine creatinine clearance done at screening.
Renally impaired subjects must have clinical laboratory test results that are considered clinically stable in the opinion of the principal investigator. Subjects with laboratory parameters outside the reference range may be included if, in the opinion of the investigator and medical monitor, these findings will not interfere with the study or introduce additional safety risk to the subject.
Body weight >= 50 kilograms (kg) and body mass index (BMI) within the range 19 - 38 kg/ meter (m)^2 (inclusive)

Key exclusion criteria (65 listed)

For Renally Impaired Subjects (Cohort 1)
Alanine aminotransferase (ALT) and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease (including acute or chronic hepatitis B and C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Corrected QT Interval (QTc) > 480 millisecond (msec)
The QTc is the QT interval corrected for heart rate according to Fridericia's formula (QTcF) machine-read or manually over-read.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK1265744 30 mgWhite to almost white coated oval tablets with unit dose strength of 30 mg for oral administrations.	Drug	Subjects with normal renal function, Subjects with renal impairment

Primary outcome

Composite of PK parameters evaluated by measurement of AUC (0-infinity) and Cmax following single oral dose.
Time frame: Samples will be collected at pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
To compare effect of severe renal impairment on PK parameters for 744 assessed by Area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinity]) and Maximum observed concentration (Cmax)

6 secondary outcomes

Unbound concentration and unbound fraction in plasma of GSK1265744 at 2 and 24 hours post dose
Time frame: Samples will be collected at 2 and 24 hours post dose.
Composite of PK parameters for GSK1265744 evaluated by measurement of Plasma AUC(0-t), %AUCex, C24, t1/2, CL/F, tlag, tmax and Vz/F following a single oral dose
Time frame: Samples will be collected at pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.
Number of participants with adverse events as measure of safety and tolerability
Time frame: Day -1 to Day 15
Safety and tolerability of single oral dose of 744 assessed by clinical laboratory tests
Time frame: 14 Days
Safety and tolerability of single oral dose of 744 assessed by12-Lead electrocardiogram
Time frame: 2 Days
Safety and tolerability of single oral dose of 744 assessed by vital signs
Time frame: 14 Days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
Background: PubMed 30809978Parasrampuria R, Ford SL, Lou Y, Fu C, Bakshi KK, Tenorio AR, Trezza C, Spreen WR, Patel P. A Phase I Study to Evaluate the Pharmacokinetics and Safety of Cabotegravir in Adults With Severe Renal Impairment and Healthy Matched Control Participants. Clin Pharmacol Drug Dev. 2019 Jul;8(5):674-681. doi: 10.1002/cpdd.664. Epub 2019 Feb 27.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

ViiV Healthcare

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK1265744 30 mg 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 16 inclusion and 65 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 28 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Composite of PK parameters evaluated by measurement of AUC (0-infinity) and Cmax following single oral dose. (time frame: Samples will be collected at pre-dose (within 15 minutes prior to dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120 and 168 hours post dose.). 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 NCT02354937, which also lists 1 linked publication.

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 28 Aug 2020.