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ClinicalTrials.gov public records Last synced Sep 30, 2026, 2:33 AM EDT

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Showing 1–24 of 27 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Oral Cabotegravir (CAB) Clear all
Completed Phase 2 Interventional Results available

Phase 2b, Open-label, Multicenter, Rollover Study to Assess Antiviral Activity and Safety of Long-acting (LA) Cabotegravir (CAB) Plus LA Rilpivirine (RPV), Administered Every 2 Months (Q2M), in Human Immunodeficiency Virus (HIV)-Positive Participants From the LATTE Study

NCT03639311
View directory record Official record
Conditions
HIV Infections
Interventions
CAB LA, RPV LA, RPV, DTG
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
97 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2023
U.S. locations
25
States / cities
Phoenix, Arizona • Bakersfield, California • Beverly Hills, California + 20 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2024 · Synced Sep 30, 2026, 2:33 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 12, 2024 · Synced Sep 30, 2026, 2:33 AM EDT
Completed 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 Sep 17, 2026 · Synced Sep 30, 2026, 2:33 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 14, 2026 · Synced Sep 30, 2026, 2:33 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 16, 2014 · Synced Sep 30, 2026, 2:33 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 20, 2025 · Synced Sep 30, 2026, 2:33 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 23, 2025 · Synced Sep 30, 2026, 2:33 AM EDT
Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

NCT06411223
View directory record Official record
Conditions
Hiv
Interventions
Collaborative drug therapy management model, Cabotegravir/Rilpivirine
Behavioral · Drug
Lead sponsor
Yale University
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2027
U.S. locations
1
States / cities
New Haven, Connecticut
Source: ClinicalTrials.gov public record
Updated Feb 3, 2026 · Synced Sep 30, 2026, 2:33 AM EDT
Withdrawn Phase 1Phase 2 Interventional

CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

NCT06336434
View directory record Official record
Conditions
HIV-1-infection, Pregnancy, Postpartum
Interventions
CAB LA 600mg, RPV LA 900mg, CAB LA 400mg, RPV LA 600mg
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
18 Years and older · Female only
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2028
U.S. locations
4
States / cities
La Jolla, California • Los Angeles, California • Baltimore, Maryland + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 31, 2025 · Synced Sep 30, 2026, 2:33 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 27, 2026 · Synced Sep 30, 2026, 2:33 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 15, 2025 · Synced Sep 30, 2026, 2:33 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 22, 2025 · Synced Sep 30, 2026, 2:33 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 19, 2026 · Synced Sep 30, 2026, 2:33 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 19, 2026 · Synced Sep 30, 2026, 2:33 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 29, 2026 · Synced Sep 30, 2026, 2:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effect of Rifampin (RIF) on the Pharmacokinetics (PK) of Oral Cabotegravir (CAB) in Healthy Subjects

NCT02411435
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus
Interventions
CAB, RIF
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 65 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Jan 6, 2016 · Synced Sep 30, 2026, 2:33 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 8, 2026 · Synced Sep 30, 2026, 2:33 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 29, 2026 · Synced Sep 30, 2026, 2:33 AM EDT
Recruiting No phase listed Observational

HIV Outpatient Monitoring Evaluation Through Self-collection of Dried Blood Spots

NCT04979728
View directory record Official record
Conditions
HIV Treatment, HIV Prevention
Interventions
At Home Self-Collections
Other
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2027
U.S. locations
1
States / cities
Aurora, Colorado
Source: ClinicalTrials.gov public record
Updated Mar 3, 2026 · Synced Sep 30, 2026, 2:33 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 4, 2024 · Synced Sep 30, 2026, 2:33 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 14, 2025 · Synced Sep 30, 2026, 2:33 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
38
States / cities
Birmingham, Alabama • Beverly Hills, California • Los Angeles, California + 26 more
Source: ClinicalTrials.gov public record
Updated Sep 15, 2026 · Synced Sep 30, 2026, 2:33 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 28, 2026 · Synced Sep 30, 2026, 2:33 AM EDT
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 30, 2026 · Synced Sep 30, 2026, 2:33 AM EDT