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ClinicalTrials.gov public records Last synced Oct 26, 2026, 6:41 AM EDT

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Showing 1–24 of 57 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: Cabotegravir Injection Clear all
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 26, 2026, 6:41 AM 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 26, 2026, 6:41 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Withdrawn Phase 1Phase 2 Interventional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 Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 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 10, 2014 · Synced Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 AM 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 18, 2025 · Synced Oct 26, 2026, 6:41 AM 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 26, 2026, 6:41 AM EDT
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 Oct 26, 2026, 6:41 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 Oct 21, 2026 · Synced Oct 26, 2026, 6:41 AM 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 Oct 5, 2026 · Synced Oct 26, 2026, 6:41 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
44
States / cities
Birmingham, Alabama • Beverly Hills, California • Los Angeles, California + 29 more
Source: ClinicalTrials.gov public record
Updated Oct 21, 2026 · Synced Oct 26, 2026, 6:41 AM EDT
Completed Phase 3 Interventional Results available

Study to Identify and Determine Best Implementation Practices for Injectable Cabotegravir+Rilpivirine in the United States (US)

NCT04001803
View directory record Official record
Conditions
HIV Infections
Interventions
CAB LA+RPV LA
Drug
Lead sponsor
ViiV Healthcare
Industry
Eligibility
18 Years and older
Enrollment
115 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
9
States / cities
Sacramento, California • Washington D.C., District of Columbia • Jacksonville, Florida + 6 more
Source: ClinicalTrials.gov public record
Updated Apr 14, 2023 · Synced Oct 26, 2026, 6:41 AM 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 26, 2026, 6:41 AM EDT
Recruiting Phase 4 Interventional

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

NCT07199335
View directory record Official record
Conditions
HIV, Substance Use Disorder (SUD), Injection Drug Use
Interventions
APRETUDE (cabotegravir)
Drug
Lead sponsor
Massachusetts General Hospital
Other
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
2
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 19, 2026 · Synced Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 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 18, 2021 · Synced Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 AM EDT
Not yet recruiting Phase 4 Interventional Accepts healthy volunteers

NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings

NCT06854029
View directory record Official record
Conditions
HIV Infections, Opioid Use Disorder, Incarceration; Lens
Interventions
Cabotegravir Injection, Cabotegravir Pill, Buprenorphine injection, Buprenorphine Pill
Drug
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
450 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2026 – 2030
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Aug 26, 2026 · Synced Oct 26, 2026, 6:41 AM 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 28, 2025 · Synced Oct 26, 2026, 6:41 AM 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 22, 2024 · Synced Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 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 Oct 26, 2026, 6:41 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 Oct 13, 2026 · Synced Oct 26, 2026, 6:41 AM EDT