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Showing 1–24 of 45 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: GSK1265744 Oral Clear all
Active, not recruiting Phase 3 Interventional Results available

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

NCT02938520
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), ABC/DTG/3TC STR - Tablet, DTG Tablet
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
631 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2029
U.S. locations
25
States / cities
Birmingham, Alabama • Bakersfield, California • Long Beach, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Randomized Study to Assess the Relative Bioavailability of New Formulations of GSK1265744 Long Acting Parental (LAP) in Healthy Adult Subjects

NCT01754116
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
GSK1265744 30 mg oral, Midazolam 3 mg oral + GSK1265744 30mg oral, GSK1265744 400 mg (200 nm), GSK1265744 400 mg (1 micro m), GSK1265744 400 mg (5 micro m)
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years
Enrollment
43 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013 – 2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Apr 20, 2014 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Relative Bioavailability Study of GSK1265744 Formulations

NCT01648257
View directory record Official record
Conditions
Infections, Human Immunodeficiency Virus and Hepatitis
Interventions
GSK1265744 Na Salt Tablets, GSK1265744 Free Acid Nanomilled Capsules, GSK1265744 Free Acid Micronized Capsules
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 64 Years
Enrollment
18 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Aug 11, 2016 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 4 Interventional Results available

Parrying the Pitfalls of PrEP: Project PEACH

NCT05072093
View directory record Official record
Conditions
HIV, STI
Interventions
PrEP discontinuation intervention, Offering of on-demand oral PrEP, Offering of STI PEP, Injectable PrEP
Behavioral · Drug
Lead sponsor
Emory University
Other
Eligibility
18 Years to 45 Years · Male only
Enrollment
240 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Mar 31, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Terminated No phase listed Observational Accepts healthy volunteers

A Pharmacist-run PrEP Program for Women

NCT05755204
View directory record Official record
Conditions
HIV Prevention
Interventions
LA-CAB, TDF/FTC
Drug
Lead sponsor
Orlando Immunology Center
Other
Eligibility
18 Years to 65 Years · Female only
Enrollment
2 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2024
U.S. locations
1
States / cities
Orlando, Florida
Source: ClinicalTrials.gov public record
Updated Feb 13, 2025 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1Phase 2 Interventional Results available

More Options for Children and Adolescents (MOCHA): Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in HIV-Infected Children and Adolescents

NCT03497676
View directory record Official record
Conditions
HIV Infections
Interventions
Oral Cabotegravir (CAB), Oral Rilpivirine (RPV), Long-Acting Injectable Cabotegravir (CAB LA), Long-Acting Injectable Rilpivirine (RPV LA), Combination Antiretroviral Therapy (cART)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
12 Years to 17 Years
Enrollment
168 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2025
U.S. locations
8
States / cities
Los Angeles, California • Aurora, Colorado • Miami, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Jan 27, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Active, not recruiting Phase 3 Interventional Results available

The LATITUDE Study: Long-Acting Therapy to Improve Treatment SUccess in Daily LifE

NCT03635788
View directory record Official record
Conditions
HIV Infections
Interventions
Standard of Care (SOC) Oral ART, Oral RPV, Oral CAB, RPV-LA Loading Dose, CAB-LA Loading Dose, RPV-LA Maintenance Dose, CAB-LA Maintenance Dose
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
456 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
32
States / cities
Birmingham, Alabama • Los Angeles, California • San Diego, California + 24 more
Source: ClinicalTrials.gov public record
Updated Jun 23, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects

NCT01848340
View directory record Official record
Conditions
HIV-associated Lipodystrophy Syndrome
Interventions
GSK1265744B (sodium salt) containing 14C-GSK1265744B, 150 mg GSK1265744B, Placebo
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 60 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Nov 3, 2013 · Synced Sep 5, 2026, 4:10 AM EDT
Not yet recruiting Not applicable Interventional Accepts healthy volunteers

Linking Youth to Pre-Exposure Prophylaxis (PrEP) Services

NCT07438041
View directory record Official record
Conditions
HIV, PrEP, PrEP Adherence
Interventions
LYPS, Enhanced Standard of Care
Other
Lead sponsor
Westat
Other
Eligibility
13 Years to 24 Years
Enrollment
272 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2028
U.S. locations
4
States / cities
San Francisco, California • Atlanta, Georgia • Baltimore, Maryland + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 12, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Evaluating the Safety, Tolerability, and Pharmacokinetics of an Investigational, Injectable HIV Medicine (GSK1265744) in HIV-Uninfected Adults

NCT02178800
View directory record Official record
Conditions
HIV Infections
Interventions
GSK1265744 Tablets, Injectable GSK1265744, Placebo for GSK1265744 Tablets, Injectable Placebo for GSK1265744
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years to 65 Years
Enrollment
199 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2018
U.S. locations
4
States / cities
Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 1 more
Source: ClinicalTrials.gov public record
Updated Oct 17, 2021 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Not applicable Interventional Results available

Improving Treatment and Retention Adherence in Nontraditional Settings

NCT04973254
View directory record Official record
Conditions
HIV Infections
Interventions
CAB-RPV LA, Standard treatment within an HIV clinic
Other
Lead sponsor
Boston Medical Center
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 14, 2025 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Assess The Relative Bioavailability of New Tablet Formulations of GSK1265744 in Healthy Adult Subjects

NCT02059031
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
GSK1265744 Reference formulation, GSK1265744 New formulation 1, GSK1265744 New formulation 2
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jul 15, 2014 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

A Study Evaluating Implementation Strategies for the Delivery of APRETUDE for Black cis-and Transgender Women in United States EHE Territories

NCT05514509
View directory record Official record
Conditions
HIV Infections
Interventions
APRETUDE, Cabotegravir tablet
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older · Female only
Enrollment
370 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2025
U.S. locations
22
States / cities
Washington D.C., District of Columbia • Miami, Florida • Orlando, Florida + 13 more
Source: ClinicalTrials.gov public record
Updated Feb 8, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805
View directory record Official record
Conditions
HIV Infections
Interventions
CAB LA + RPV LA, Oral ART
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
12 Years and older
Enrollment
326 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
39
States / cities
Birmingham, Alabama • Los Angeles, California • Aurora, Colorado + 29 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 2Phase 3 Interventional Accepts healthy volunteers Results available

Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men

NCT02720094
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Oral Tablet, TDF/FTC tablets, Placebo for TDF/FTC tablets, Placebo for cabotegravir oral tablet, CAB LA, Placebo for CAB LA
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
4,570 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016 – 2025
U.S. locations
27
States / cities
Birmingham, Alabama • Los Angeles, California • Oakland, California + 20 more
Source: ClinicalTrials.gov public record
Updated Mar 18, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Active, not recruiting Phase 2Phase 3 Interventional

Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen

NCT05502341
View directory record Official record
Conditions
HIV-1-infection
Interventions
Bictegravir, Lenacapavir, BIC/LEN FDC, Stable Baseline Regimen
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
689 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2028
U.S. locations
40
States / cities
Berkeley, California • Beverly Hills, California • Los Angeles, California + 34 more
Source: ClinicalTrials.gov public record
Updated Aug 9, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Active, not recruiting Phase 3 Interventional Results available

Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults

NCT03299049
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
1,049 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2029
U.S. locations
43
States / cities
Birmingham, Alabama • Phoenix, Arizona • Bakersfield, California + 33 more
Source: ClinicalTrials.gov public record
Updated Aug 21, 2025 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Study to Evaluate Pharmacokinetic (PK), Safety and Tolerability of Cabotegravir (CAB) 400 Milligrams Per Milliliter (mg/mL) Formulation in Healthy Adult Participants

NCT04484337
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir sodium (Oral Lead In), Cabotegravir 400 mg/mL, Cabotegravir 200 mg/mL, Topical Non-steroidal anti-inflammatory drug (NSAID), Topical steroid, Topical NSAID placebo, Recombinant human hyaluronidase PH20 (rHuPH20), Topical steroid placebo
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
138 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
4
States / cities
Orlando, Florida • Las Vegas, Nevada • Berlin, New Jersey + 1 more
Source: ClinicalTrials.gov public record
Updated May 28, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Recruiting Phase 3 Interventional

Study of Lenacapavir, Teropavimab, and Zinlirvimab Versus Cabotegravir and Rilpivirine in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy

NCT07682961
View directory record Official record
Conditions
HIV Infections
Interventions
Lenacapavir, Lenacapavir Tablet, Teropavimab, Zinlirvimab, Cabotegravir, Rilpivirine
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
590 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2033
U.S. locations
16
States / cities
San Francisco, California • DeLand, Florida • Fort Lauderdale, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Aug 13, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Recruiting No phase listed Observational

Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention

NCT07473778
View directory record Official record
Conditions
HIV Infections
Interventions
Lenacapavir Injection, Emtricitabine/tenofovir disoproxil fumarate (F/TDF), Emtricitabine/tenofovir alafenamide (F/TAF), Cabotegravir (CAB), Lenacapavir Tablet
Drug
Lead sponsor
Gilead Sciences
Industry
Eligibility
18 Years and older
Enrollment
3,000 participants
Timeline
2026 – 2029
U.S. locations
34
States / cities
Birmingham, Alabama • Beverly Hills, California • Los Angeles, California + 23 more
Source: ClinicalTrials.gov public record
Updated Aug 18, 2026 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

NCT04542070
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Tablets, Cabotegravir Injectable Suspension (CAB LA), Rilpivirine Tablets, Rilpivirine Injectable Suspension (RPV LA), BIKTARVY Tablets (BIK)
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
687 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2023
U.S. locations
41
States / cities
Bakersfield, California • Beverly Hills, California • Los Angeles, California + 32 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2024 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional

Pharmacokinetics Study of GSK1265744 in Subjects With Severe Renal Impairment

NCT02354937
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus, HIV Infections
Interventions
GSK1265744 30 mg
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 70 Years
Enrollment
16 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
2
States / cities
Lakewood, Colorado • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 27, 2020 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 2 Interventional Results available

A Phase IIb Study to Evaluate a Long-Acting Intramuscular Regimen for Maintenance of Virologic Suppression (Following Induction With an Oral Regimen of GSK1265744 and Abacavir/Lamivudine) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected, Antiretroviral Therapy-Naive Adult Subjects

NCT02120352
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus, HIV Infections
Interventions
CAB Oral Tablets, CAB LA, ABC/3TC Oral tablets, RPV Oral Tablets, HAART, RPV
Drug · Other
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
309 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2023
U.S. locations
15
States / cities
Birmingham, Alabama • Bakersfield, California • Beverly Hills, California + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2024 · Synced Sep 5, 2026, 4:10 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Healthy Volunteer Study To Assess The Bioavailability of GSK1265744 When Administered Orally Either When Fasted or Following a Meal.

NCT00812318
View directory record Official record
Conditions
HIV Infection, Infection, Human Immunodeficiency Virus
Interventions
GSK1265744 10 mg oral solution, GSK1265744 5 mg tablet
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 55 Years
Enrollment
45 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2008
U.S. locations
1
States / cities
Buffalo, New York
Source: ClinicalTrials.gov public record
Updated Apr 1, 2012 · Synced Sep 5, 2026, 4:10 AM EDT