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
Public ClinicalTrials.gov record NCT07650916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Cabotegravir Ultra Long-acting Plus Rilpivirine Ultra Long-acting or Cabotegravir Long-acting Plus Rilpivirine Long-acting in Adults and Adolescents With HIV Who Are Virologically Suppressed on ART
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compares the efficacy, safety and tolerability of CAB ULA and RPV ULA administered with CAB long acting (LA) and RPV LA administered in adults and adolescents with HIV who are virologically suppressed on anti-retroviral therapy (ART).
Study identification
- NCT ID
- NCT07650916
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 564 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 24, 2026
- Primary completion
- Sep 3, 2029
- Completion
- Sep 3, 2029
- Last update posted
- Aug 2, 2026
2026 – 2029
United States locations
- U.S. sites
- 35
- U.S. states
- 19
- U.S. cities
- 32
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85015 | Recruiting |
| GSK Investigational Site | Bakersfield | California | 93301 | Recruiting |
| GSK Investigational Site | Los Angeles | California | 90027 | Recruiting |
| GSK Investigational Site | Los Angeles | California | 90036 | Recruiting |
| GSK Investigational Site | San Diego | California | 92103 | Recruiting |
| GSK Investigational Site | New Haven | Connecticut | 06510 | Recruiting |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20017 | Recruiting |
| GSK Investigational Site | DeLand | Florida | 32720 | Recruiting |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | Recruiting |
| GSK Investigational Site | Ft. Pierce | Florida | 34982 | Recruiting |
| GSK Investigational Site | Miami | Florida | 33136 | Recruiting |
| GSK Investigational Site | Orlando | Florida | 32803 | Recruiting |
| GSK Investigational Site | Pensacola | Florida | 32503 | Recruiting |
| GSK Investigational Site | Vero Beach | Florida | 32960 | Recruiting |
| GSK Investigational Site | West Palm Beach | Florida | 33407 | Recruiting |
| GSK Investigational Site | West Palm Beach | Florida | 33409 | Recruiting |
| GSK Investigational Site | Decatur | Georgia | 30033 | Recruiting |
| GSK Investigational Site | Grosse Pointe Woods | Michigan | 48236 | Recruiting |
| GSK Investigational Site | Kansas City | Missouri | 64111 | Recruiting |
| GSK Investigational Site | Las Vegas | Nevada | 89101 | Recruiting |
| GSK Investigational Site | Newark | New Jersey | 07102 | Recruiting |
| GSK Investigational Site | Santa Fe | New Mexico | 87505 | Recruiting |
| GSK Investigational Site | Stony Brook | New York | 11794 | Recruiting |
| GSK Investigational Site | Syracuse | New York | 13057 | Recruiting |
| GSK Investigational Site | Greensboro | North Carolina | 27401 | Recruiting |
| GSK Investigational Site | Columbus | Ohio | 43210 | Recruiting |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | Recruiting |
| GSK Investigational Site | Austin | Texas | 78705 | Recruiting |
| GSK Investigational Site | Dallas | Texas | 75219 | Recruiting |
| GSK Investigational Site | Dallas | Texas | 75246 | Recruiting |
| GSK Investigational Site | El Paso | Texas | 79902 | Recruiting |
| GSK Investigational Site | Houston | Texas | 77098 | Recruiting |
| GSK Investigational Site | Salt Lake City | Utah | 84102 | Recruiting |
| GSK Investigational Site | Lynchburg | Virginia | 24501 | Recruiting |
| GSK Investigational Site | Seattle | Washington | 98104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 19 non-U.S. sites.
Recently updated HIV Infections trials
Other public records listing HIV Infections. Sorted by last update posted; newest first. Not a recommendation.
- NCT06679751: Infectious Disease (ID) Testing OUtreach in Carceral Hubs Active, not recruiting
- NCT05996471: A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV) Active, not recruiting
- NCT03729778: Impact of HIV-1 and Aging on Mucosal Vaccine Responses Active, not recruiting
- NCT07728123: Screen2Prevent (S2P) Recruiting
- NCT06316739: The Ganchero Intervention for Migrant People Who Inject Drugs From Puerto Rico in New York City Active, not recruiting
- NCT07202546: A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) Recruiting
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07650916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 2, 2026 · Synced Aug 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07650916 live on ClinicalTrials.gov.