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Showing 1–24 of 55 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Cabotegravir long-acting Clear all
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 24, 2026, 4:04 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 28, 2023 · Synced Sep 24, 2026, 4:04 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 27, 2026 · Synced Sep 24, 2026, 4:04 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 21, 2020 · Synced Sep 24, 2026, 4:04 PM 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 24, 2026, 4:04 PM 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 24, 2026, 4:04 PM 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 2, 2026 · Synced Sep 24, 2026, 4:04 PM 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 16, 2026 · Synced Sep 24, 2026, 4:04 PM EDT
Terminated Not applicable Interventional Accepts healthy volunteers

Long-acting Biomedical HIV Prevention in Transgender Women

NCT03856580
View directory record Official record
Conditions
HIV Prevention, Transgender Women
Interventions
Alternative long-acting PrEP injection strategies, mHealth adherence app
Behavioral
Lead sponsor
University of Colorado, Denver
Other
Eligibility
18 Years to 100 Years · Male only
Enrollment
19 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2023
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Oct 3, 2024 · Synced Sep 24, 2026, 4:04 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 28, 2026 · Synced Sep 24, 2026, 4:04 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 19, 2025 · Synced Sep 24, 2026, 4:04 PM EDT
Active, not recruiting Phase 4 Interventional

Tshireletso: Safety, Efficacy and Feasibility of Cabotegravir-LA PrEP in a Breastfeeding Population in Botswana

NCT05986084
View directory record Official record
Conditions
Pre-Exposure Prophylaxis (PrEP), Breast Feeding
Interventions
Cabotegravir Injection [Apretude]
Drug
Lead sponsor
Beth Israel Deaconess Medical Center
Other
Eligibility
18 Years and older · Female only
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2027
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jul 29, 2026 · Synced Sep 24, 2026, 4:04 PM EDT
Active, not recruiting Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate if Long Acting Cabotegravir (CAB) and Lenacapavir (LEN) Injections Are Tolerable and Acceptable When Administered to Healthy Adults Without HIV

NCT06970223
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir long-acting, Lenacapavir long-acting
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
65 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Long Beach, California
Source: ClinicalTrials.gov public record
Updated Nov 27, 2025 · Synced Sep 24, 2026, 4:04 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 22, 2025 · Synced Sep 24, 2026, 4:04 PM EDT
Terminated No phase listed Observational Results available

Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum

NCT04518228
View directory record Official record
Conditions
HIV, Tuberculosis
Interventions
Bictegravir (BIC), Tenofovir alafenamide (TAF), Long-acting injectable formulation of cabotegravir (CAB LA), Dolutegravir (DTG), Atazanavir/ritonavir (ATV/r), Darunavir/ritonavir (DRV/r), Lopinavir/ritonavir (LPV/r), Cobicistat, Ritonavir, First-Line TB Treatment, Second-Line TB Treatment, Doravirine (DOR)
Drug
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eligibility
Not listed
Enrollment
205 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
13
States / cities
Los Angeles, California • San Diego, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 24, 2026, 4:04 PM 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 24, 2026, 4:04 PM EDT
Withdrawn Phase 2 Interventional Accepts healthy volunteers

Combined Injectable Treatment for HIV and OUD

NCT05991622
View directory record Official record
Conditions
Human Immunodeficiency Virus, Opioid Use Disorder
Interventions
Combined LAI Treatment: Cabenuva and Sublocade
Drug
Lead sponsor
Rhode Island Hospital
Other
Eligibility
18 Years to 65 Years
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2026
U.S. locations
1
States / cities
Providence, Rhode Island
Source: ClinicalTrials.gov public record
Updated Feb 17, 2026 · Synced Sep 24, 2026, 4:04 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Pharmacokinetic Study of Cabotegravir and Rilpivirine Long-acting Intramuscular Injections in Healthy Adult Participants

NCT04371380
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Tablets, Rilpivirine Tablets, Cabotegravir extended release suspension for injection (long-acting), Rilpivirine extended release suspension for injection (long-acting)
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 50 Years
Enrollment
15 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2021
U.S. locations
1
States / cities
Glendale, California
Source: ClinicalTrials.gov public record
Updated Apr 21, 2024 · Synced Sep 24, 2026, 4:04 PM EDT
Active, not recruiting Phase 2 Interventional Accepts healthy volunteers

A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a New Formulation of Cabotegravir Long-Acting Administered Intramuscularly in a 4-month Dosing Interval (Q4M)

NCT06741397
View directory record Official record
Conditions
HIV Infections
Interventions
CAB LA, New formulation of CAB LA
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
16 Years and older
Enrollment
229 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2029
U.S. locations
25
States / cities
Birmingham, Alabama • Los Angeles, California • Palm Springs, California + 19 more
Source: ClinicalTrials.gov public record
Updated Nov 17, 2025 · Synced Sep 24, 2026, 4:04 PM EDT
Not yet recruiting No phase listed Observational

Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy

NCT07637942
View directory record Official record
Conditions
HIV -1 Infection
Interventions
Every 4-week long-acting injectable cabotegravir and rilpivirine
Drug
Lead sponsor
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Network
Eligibility
18 Years and older · Female only
Enrollment
40 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
10
States / cities
La Jolla, California • Los Angeles, California • Aurora, Colorado + 7 more
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Sep 24, 2026, 4:04 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 14, 2025 · Synced Sep 24, 2026, 4:04 PM EDT
Completed No phase listed Observational Accepts healthy volunteers

Implementation and Delivery of Cabotegravir Long Acting Injection for PrEP in a Community Pharmacy Setting.

NCT05867212
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir Injection [Apretude]
Drug
Lead sponsor
Kelley-Ross & Associates, Inc.
Other
Eligibility
18 Years and older
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2025
U.S. locations
2
States / cities
Seattle, Washington
Source: ClinicalTrials.gov public record
Updated Jul 28, 2025 · Synced Sep 24, 2026, 4:04 PM EDT
Recruiting Phase 1 Interventional Accepts healthy volunteers

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

NCT05418868
View directory record Official record
Conditions
HIV Infections
Interventions
Cabotegravir 200 mg/mL, Cabotegravir >=400 mg/mL, Cabotegravir Formulation I, CAB Formulation J, rHuPH20, RPV
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years to 55 Years
Enrollment
214 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2027
U.S. locations
3
States / cities
Orlando, Florida • Las Vegas, Nevada • Austin, Texas
Source: ClinicalTrials.gov public record
Updated Dec 17, 2025 · Synced Sep 24, 2026, 4:04 PM 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 24, 2026, 4:04 PM EDT