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ClinicalTrials.gov public records Last synced Oct 4, 2026, 5:26 PM EDT

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Showing 25–48 of 55 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Cabotegravir long-acting Clear all
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 Oct 1, 2026 · Synced Oct 4, 2026, 5:26 PM EDT
Terminated Not applicable Interventional

Implementing Cabenuva in Arkansas HIV Programs

NCT05096949
View directory record Official record
Conditions
HIV-1-infection, Medication Adherence, Satisfaction, Patient
Interventions
Home visit delivery strategy
Other
Lead sponsor
University of Arkansas
Other
Eligibility
18 Years and older
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Little Rock, Arkansas
Source: ClinicalTrials.gov public record
Updated Sep 3, 2024 · Synced Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM EDT
Not listed No phase listed Observational Accepts healthy volunteers

Oregon PrEP at Home Study

NCT05949203
View directory record Official record
Conditions
HIV/AIDS
Interventions
Cabotegravir Injection
Drug
Lead sponsor
Oregon Health and Science University
Other
Eligibility
18 Years and older
Enrollment
125 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2025
U.S. locations
1
States / cities
Portland, Oregon
Source: ClinicalTrials.gov public record
Updated Dec 6, 2023 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

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
295 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 Oct 1, 2026 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

A Study Evaluating Implementation Strategies for the Delivery of Cabotegravir in Low and High-Volume PrEP Site in the United States

NCT05374525
View directory record Official record
Conditions
HIV Infections
Interventions
APRETUDE, Cabotegravir OLI
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older · Male only
Enrollment
287 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2024
U.S. locations
17
States / cities
Los Angeles, California • San Francisco, California • Washington D.C., District of Columbia + 14 more
Source: ClinicalTrials.gov public record
Updated Dec 15, 2025 · Synced Oct 4, 2026, 5:26 PM EDT
Recruiting Not applicable Interventional Accepts healthy volunteers

The TAIL-PrEP Study

NCT06868641
View directory record Official record
Conditions
HIV Infections
Interventions
TAIL-PrEP for patients discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing cab-LA, TAIL-PrEP for patients considering discontinuing LEN
Behavioral
Lead sponsor
Columbia University
Other
Eligibility
18 Years and older
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2027
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Sep 21, 2026 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Effects of Cabotegravir (CAB) and Rilpivirine (RPV) Long-Acting (LA) Injections Following Sub-cutaneous (SC) Administration Compared With Intramuscular (IM) Administration in Adult Participants Living With Human Immunodeficiency Virus (HIV-1) Infection in the FLAIR Study

NCT05896748
View directory record Official record
Conditions
Human Immunodeficiency Virus Type 1 (HIV-1)
Interventions
Cabotegravir - Injectable Suspension (CAB LA), Rilpivirine - Injectable Suspension (RPV LA)
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
94 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
5
States / cities
Macon, Georgia • Austin, Texas • Bellaire, Texas + 2 more
Source: ClinicalTrials.gov public record
Updated Nov 26, 2024 · Synced Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM EDT
Recruiting Phase 3 Interventional

A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed

NCT07650916
View directory record Official record
Conditions
HIV Infections
Interventions
CAB ULA, RPV ULA, CAB LA, RPV LA
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
12 Years and older
Enrollment
564 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
40
States / cities
Phoenix, Arizona • Bakersfield, California • Los Angeles, California + 34 more
Source: ClinicalTrials.gov public record
Updated Sep 28, 2026 · Synced Oct 4, 2026, 5:26 PM EDT
Completed No phase listed Observational

Preparing for Pharmacy-based Delivery of Long-acting Injectable Antiretroviral Therapy (LAI-ART)

NCT05152953
View directory record Official record
Conditions
Hiv
Interventions
Not listed
Lead sponsor
University of California, San Francisco
Other
Eligibility
18 Years and older
Enrollment
63 participants
Timeline
2022 – 2023
U.S. locations
4
States / cities
Auburn, Alabama • San Francisco, California • Fort Lauderdale, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 29, 2023 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 3 Interventional

A Study Evaluating the Pharmacokinetics, Efficacy, Safety and Tolerability of CABENUVA

NCT05601128
View directory record Official record
Conditions
HIV-1-infection, HIV Infections, HIV I Infection
Interventions
CAB + RPV
Drug
Lead sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Other
Eligibility
18 Years to 89 Years
Enrollment
12 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jul 14, 2026 · Synced Oct 4, 2026, 5:26 PM EDT
Active, not recruiting No phase listed Observational

Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP

NCT06145854
View directory record Official record
Conditions
Hiv
Interventions
Cabotegravir Injection [Apretude]
Drug
Lead sponsor
Midway Specialty Care Center
Other
Eligibility
18 Years and older · Female only
Enrollment
100 participants
Timeline
2024 – 2027
U.S. locations
3
States / cities
Orlando, Florida • Temple Terrace, Florida • West Palm Beach, Florida
Source: ClinicalTrials.gov public record
Updated Nov 3, 2025 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 3 Interventional Results available

A Sub-study of Cabotegravir (CAB) and Rilpivirine (RPV) in Human Immunodeficiency Viruses (HIV)-Infected Participants

NCT05896761
View directory record Official record
Conditions
Human Immunodeficiency Virus Type 1 (HIV-1)
Interventions
Cabotegravir Injectable Suspension, Rilpivirine Injectable Suspension
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2022
U.S. locations
10
States / cities
Bakersfield, California • Fort Lauderdale, Florida • Ft. Pierce, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Sep 18, 2023 · Synced Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers

NCT02478463
View directory record Official record
Conditions
Infection, Human Immunodeficiency Virus, HIV Infections
Interventions
Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 55 Years
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017 – 2019
U.S. locations
2
States / cities
Baltimore, Maryland • Pittsburgh, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 22, 2020 · Synced Oct 4, 2026, 5:26 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Two Different Formulations of Long-acting Cabotegravir in Healthy Adult Participants

NCT06033547
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Formulation F, Cabotegravir Formulation G
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 55 Years
Enrollment
56 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2025
U.S. locations
1
States / cities
Austin, Texas
Source: ClinicalTrials.gov public record
Updated Feb 6, 2026 · Synced Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM EDT
Active, not recruiting No phase listed Observational

IMplementation of CAB+RPV LA for People With HIV in Non-Metropolitan Areas

NCT06451341
View directory record Official record
Conditions
HIV
Interventions
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), HIV Stigma Scale Questionnaire, HIV Treatment Satisfaction Questionnaire status version (HIVTSQs12), HIV Treatment Satisfaction Questionnaire change version (HIVTSQc12), Needs and Barriers Assessment, Pre-visit Outreach, Qualitative interview - patient participants, Staff education, Staff Month 7 and 15 Survey - Staff Burden and Engagement, Qualitative interview - staff
Behavioral
Lead sponsor
University of Nebraska
Other
Eligibility
19 Years and older
Enrollment
75 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
4
States / cities
Harlan, Iowa • Shenandoah, Iowa • Grand Island, Nebraska + 1 more
Source: ClinicalTrials.gov public record
Updated Jul 24, 2026 · Synced Oct 4, 2026, 5:26 PM 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 Oct 4, 2026, 5:26 PM EDT