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Showing 1–24 of 37 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Cabotegravir tablet Clear all
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 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Safety, Tolerability and Acceptability of Long-Acting Cabotegravir (CAB LA) for the Prevention of HIV Among Adolescent Males

NCT04692077
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir (CAB) tablet, CAB LA, Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Up to 17 Years · Male only
Enrollment
9 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
4
States / cities
Aurora, Colorado • Chicago, Illinois • Boston, Massachusetts + 1 more
Source: ClinicalTrials.gov public record
Updated May 19, 2025 · Synced Sep 10, 2026, 5:12 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 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 2 Interventional Results available

Dose Ranging Study of GSK1265744 Plus Nucleoside Reverse Transcriptase Inhibitors for Induction of Human Immunodeficiency Virus-1 (HIV-1) Virologic Suppression Followed by Virologic Suppression Maintenance by GSK1265744 Plus Rilpivirine

NCT01641809
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus, HIV Infections
Interventions
GSK1265744 10 mg, GSK1265744 30 mg, GSK1265744 60 mg, Efavirenz 600 mg, Rilpivirine 25 mg, Placebo, Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
244 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2019
U.S. locations
40
States / cities
Birmingham, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 35 more
Source: ClinicalTrials.gov public record
Updated Jan 29, 2020 · Synced Sep 10, 2026, 5:12 AM EDT
Active, not recruiting Phase 3 Interventional Results available

Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults

NCT02951052
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus, HIV Infections
Interventions
Cabotegravir (CAB) tablet, Rilpivirine (RPV) tablet, Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA), 2 NRTIs plus an INI, NNRTI, or PI
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
618 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2029
U.S. locations
36
States / cities
Birmingham, Alabama • Phoenix, Arizona • Bakersfield, California + 28 more
Source: ClinicalTrials.gov public record
Updated Jul 7, 2026 · Synced Sep 10, 2026, 5:12 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 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate Pharmacokinetic (PK) and Safety of GSK1265744 in Subjects With Hepatic Impairment and Control Healthy Volunteers

NCT02354950
View directory record Official record
Conditions
HIV Infections
Interventions
GSK1265744 30mg
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 70 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2016
U.S. locations
3
States / cities
Lakewood, Colorado • Orlando, Florida • Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Aug 4, 2020 · Synced Sep 10, 2026, 5:12 AM EDT
Recruiting Phase 1Phase 2 Interventional

Study of Oral and Long-Acting Injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living With HIV-1, Two to Less Than 12 Years of Age

NCT05660980
View directory record Official record
Conditions
HIV-1-infection
Interventions
Once daily CAB tablet + RPV tablet, Long acting CAB injectable + long acting RPV injectable
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
2 Years to 11 Years
Enrollment
90 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
2
States / cities
Atlanta, Georgia • Memphis, Tennessee
Source: ClinicalTrials.gov public record
Updated May 18, 2026 · Synced Sep 10, 2026, 5:12 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate the Effect of GSK1265744 on Cardiac Conduction

NCT02027454
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
GSK1265744, GSK1265744 matching placebo, Moxifloxacin
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 55 Years
Enrollment
42 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jun 15, 2014 · Synced Sep 10, 2026, 5:12 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeat Dose Administration of Long-Acting GSK1265744 and Long-Acting TMC278 Intramuscular and Subcutaneous Injections in Healthy Adult Subjects

NCT01593046
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
GSK1265744 Oral, GSK1265744 LAP 800mg intramuscular injection, GSK1265744 LAP 200mg subcutaneous injection, GSK1265744 LAP 200mg intramuscular injection, GSK1265744 LAP 400mg intramuscular injection, TMC278 LA 1200mg intramuscular injection, TMC278 LA 600mg intramuscular injection
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 64 Years
Enrollment
43 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2013
U.S. locations
2
States / cities
Daytona Beach, Florida • Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Feb 9, 2014 · Synced Sep 10, 2026, 5:12 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 10, 2026, 5:12 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 10, 2026, 5:12 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 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Relative Bioavailability Study of Phase III Tablet Formulation of Cabotegravir

NCT02345707
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
Cabotegravir 30 mg current formulation, Cabotegravir 30 mg micronized new formulation 500 M, Cabotegravir 30 mg unmicronized new formulation 500 U, Cabotegravir 30 mg micronized new formulation 650 M, Cabotegravir 30 mg unmicronized new formulation 650 U
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jul 12, 2015 · Synced Sep 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 2 Interventional Results available

Long-Acting Cabotegravir Plus VRC-HIVMAB075-00-AB (VRC07-523LS) for Viral Suppression in Adults Living With HIV-1

NCT03739996
View directory record Official record
Conditions
HIV Infections
Interventions
Oral Cabotegravir (CAB), Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Long-Acting Injectable Cabotegravir (CAB LA), VRC07-523LS, Standard of Care (SOC) ART
Drug · Biological
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2024
U.S. locations
17
States / cities
Birmingham, Alabama • San Diego, California • San Francisco, California + 12 more
Source: ClinicalTrials.gov public record
Updated May 22, 2025 · Synced Sep 10, 2026, 5:12 AM EDT
Completed Phase 3 Interventional

A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy

NCT05917509
View directory record Official record
Conditions
HIV Infections
Interventions
DTG/3TC, Cabotegravir (CAB) LA, Rilpivirine (RPV) LA
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
171 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2026
U.S. locations
15
States / cities
Birmingham, Alabama • Bakersfield, California • Fort Lauderdale, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated May 26, 2026 · Synced Sep 10, 2026, 5:12 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Evaluate the Effect of High Fat Meal on Cabotegravir

NCT02799264
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
Cabotegravir 30 mg
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2016
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 12, 2017 · Synced Sep 10, 2026, 5:12 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 10, 2026, 5:12 AM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Study to Evaluate the Safety Tolerability and Acceptability of Long Acting Injections of the Human Immunodeficiency Virus (HIV) Integrase Inhibitor, GSK1265744, in HIV Uninfected Men (ECLAIR)

NCT02076178
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
744 Tablet, 744 LA Injection, Placebo Tablet, Placebo Injection
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years · Male only
Enrollment
127 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2014 – 2016
U.S. locations
10
States / cities
San Francisco, California • Washington D.C., District of Columbia • Atlanta, Georgia + 5 more
Source: ClinicalTrials.gov public record
Updated Dec 14, 2017 · Synced Sep 10, 2026, 5:12 AM EDT