AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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 3Ages 12 Years - anyAllViiV Healthcare
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ200 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.
๐Ÿ’Š

What it tests

  • CAB ULA
  • RPV ULA
  • CAB LA
  • RPV LA
๐Ÿ“

Where

108 sites
GSK Investigational Site
Phoenix, United States
GSK Investigational Site
Bakersfield, United States
GSK Investigational Site
Los Angeles, United States
GSK Investigational Site
Los Angeles, United States
GSK Investigational Site
San Diego, United States
GSK Investigational Site
West Hollywood, United States
GSK Investigational Site
New Haven, United States
GSK Investigational Site
Washington D.C., United States

โ€ฆand 100 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy