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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

RecruitingPhase 3

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

Who can join

Ages 12 and older · All sexes

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: ViiV Healthcare · Participants: 564 · Started: Jun 25, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07650916

Locations in the U.S.

ArizonaGSK Investigational Site, Phoenix
CaliforniaGSK Investigational Site, Bakersfield
GSK Investigational Site, Los Angeles
GSK Investigational Site, Los Angeles
GSK Investigational Site, San Diego
GSK Investigational Site, West Hollywood
ConnecticutGSK Investigational Site, New Haven
District of ColumbiaGSK Investigational Site, Washington D.C.
FloridaGSK Investigational Site, DeLand
GSK Investigational Site, Fort Lauderdale
GSK Investigational Site, Ft. Pierce
GSK Investigational Site, Jacksonville
GSK Investigational Site, Miami
GSK Investigational Site, Orlando
GSK Investigational Site, Pensacola
GSK Investigational Site, Vero Beach
GSK Investigational Site, West Palm Beach
GSK Investigational Site, West Palm Beach
GeorgiaGSK Investigational Site, Decatur
MarylandGSK Investigational Site, Baltimore
MichiganGSK Investigational Site, Grosse Pointe Woods
MissouriGSK Investigational Site, Kansas City
NevadaGSK Investigational Site, Las Vegas
New JerseyGSK Investigational Site, Newark
New MexicoGSK Investigational Site, Santa Fe
New YorkGSK Investigational Site, Stony Brook
GSK Investigational Site, Syracuse
North CarolinaGSK Investigational Site, Greensboro
GSK Investigational Site, Winston-Salem
OhioGSK Investigational Site, Columbus
PennsylvaniaGSK Investigational Site, Philadelphia
GSK Investigational Site, Pittsburgh
TexasGSK Investigational Site, Austin
GSK Investigational Site, Dallas
GSK Investigational Site, Dallas
GSK Investigational Site, El Paso
GSK Investigational Site, Houston
UtahGSK Investigational Site, Salt Lake City
VirginiaGSK Investigational Site, Lynchburg
WashingtonGSK Investigational Site, Seattle
GSK Investigational Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.