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Clinical Trials in the UK / NCT07650916
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
ViiV Healthcare
Phase
Phase 3
Started
2026-06-25
Last updated
2026-08-14

Condition(s) studied

HIV Infections

Investigational drug(s) / intervention(s)

CAB ULARPV ULACAB LARPV LA

CAB ULA: CAB ULA will be administered.

RPV ULA: RPV ULA will be administered.

CAB LA: CAB LA will be administered.

RPV LA: RPV LA will be administered.

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Inclusion criteria: Patient Study Participant (PSP) Inclusion criteria: * Adults and adolescents with HIV-1 infection aged 12 years or older with a weight \>35 kg. * Documented HIV-1 RNA measurements \<50 copies/mL in the 12 months prior to Screening. * HIV-1 RNA \<50 copies/mL at screening assessment. * Must be on current daily oral antiretroviral regimen for at least 6 months uninterrupted prior to Screening. * Any prior switch in therapy must have occurred due to tolerability/safety, access to medications, or convenience/simplification, and must NOT have been done for virologic treatment failure (HIV-1 RNA ≥200 copies/mL). Exclusion criteria: Patient Study Participant (PSP) Exclusion criteria: * Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation. * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. * Any history of receiving long-acting therapy for HIV. * Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection. * Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (88)

FacilityCityRegionStatus
GSK Investigational Site Phoenix Arizona Recruiting
GSK Investigational Site Bakersfield California Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site San Diego California Recruiting
GSK Investigational Site New Haven Connecticut Recruiting
GSK Investigational Site Washington D.C. District of Columbia Recruiting
GSK Investigational Site DeLand Florida Recruiting
GSK Investigational Site Fort Lauderdale Florida Recruiting
GSK Investigational Site Ft. Pierce Florida Recruiting
GSK Investigational Site Miami Florida Recruiting
GSK Investigational Site Orlando Florida Recruiting
GSK Investigational Site Pensacola Florida Recruiting
GSK Investigational Site Vero Beach Florida Recruiting
GSK Investigational Site West Palm Beach Florida Recruiting
GSK Investigational Site West Palm Beach Florida Recruiting
GSK Investigational Site Decatur Georgia Recruiting
GSK Investigational Site Grosse Pointe Woods Michigan Recruiting
GSK Investigational Site Kansas City Missouri Recruiting
GSK Investigational Site Las Vegas Nevada Recruiting
GSK Investigational Site Newark New Jersey Recruiting
GSK Investigational Site Santa Fe New Mexico Recruiting
GSK Investigational Site Stony Brook New York Recruiting
GSK Investigational Site Syracuse New York Recruiting
GSK Investigational Site Greensboro North Carolina Recruiting
GSK Investigational Site Columbus Ohio Recruiting
GSK Investigational Site Philadelphia Pennsylvania Recruiting
GSK Investigational Site Austin Texas Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site Dallas Texas Recruiting
GSK Investigational Site El Paso Texas Recruiting
GSK Investigational Site Houston Texas Recruiting
GSK Investigational Site Salt Lake City Utah Recruiting
GSK Investigational Site Lynchburg Virginia Recruiting
GSK Investigational Site Seattle Washington Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Ciudad Autonoma Buenos Aires Argentina Recruiting
GSK Investigational Site Ciudad Autonoma Buenos Aires Argentina Recruiting

+ 48 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07650916 on ClinicalTrials.gov ↗ ← All trials in the UK