Who is eligible for clinical trial NCT06694805?

Participants must meet the protocol's inclusion criteria for HIV Infections. The stated age range is 12 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT06694805 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-28

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1 (NCT06694805)

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1 (CROWN)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: ViiV Healthcare

🩺 Plain-English Summary (8th-Grade Level)

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy (ART) using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (41 items).

Location: GSK Investigational Site — Birmingham, Alabama

Age range: 12 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Age 1\. Aged \>=12 years and \>=35 kg (at the time of obtaining informed consent).
Type of Participant and Disease Characteristics 2.HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA VL.
Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient virologic response to participant's current oral ART regimen within 18 months prior to study entry according to at least 1 of the following criteria: i.\<1 log10 decrease in HIV-1 RNA or HIV-1 RNA \>200 c/mL at 2 time points at least 4 weeks apart in individuals who have been prescribed oral ART for at least 3 consecutive months. ii. Documented lapse in current oral ART regimen usage expected to result in HIV-1 viremia (defined as at least a 30-day consecutive period of non-use of oral ART) iii. Documented need for change from oral ART regimen that investigator attributes as primary reason for insufficient virologic response (e.g., safety findings and/or limited tolerability, clinically relevant DDIs). Currently being treated with an oral ART regimen specific regimen to be recorded at Screening, and willing to continue taking that regimen until approximately 1 week after the Month 6 visit.
Pregnancy, Sex and Contraceptive/Barrier Requirements 5. Person of childbearing potential (POCBP) must have a negative serum or urine pregnancy test at screening and on Day 1.
Informed Consent/Assent 6.Informed consent/Assent must be provided as follows:
Adult participants (\>=18 years old) must be capable of giving signed informed consent as described in the full study protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and stated in the full study protocol.
For adolescent participants (12 to \<18 years of age at screening), the parent(s) or legal guardian must be capable of giving signed informed consent.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Medical Conditions
HIV-1 Subtype A6, if known from historical result.
Participants who are pregnant, breast/chest feeding or plan to become pregnant or breast/chest feed during the study.
Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of hyperbilirubinemia or jaundice due to Gilbert's syndrome or asymptomatic gallstones).
Individuals with both HIV and Hepatitis B virus (HBV) will be excluded from participating in studies where they would not be able to receive appropriate therapy for their HBV co-infection and therefore may be at risk of hepatitis B flare. Exclusion will be determined by evidence of HBV infection based on the results of testing at Screening for HBsAg, HBcAb, HBsAb and HBV.
History of liver cirrhosis with or without hepatitis viral co-infection.
Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification.
Participants with HCV co-infection will be excluded entry into this study if they are currently receiving anti-HCV therapy at baseline (Day 1).
Participants determined by the investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder.
History of sensitivity to any of the study medications or their components or drugs of their class, or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Participants who in the investigator's judgment, pose a significant suicidality risk. Participant's history of suicidal behaviour and/or suicidal ideation should be considered when evaluating for suicide risk.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (85 Sites)

Showing the first 25 of 85 sites.

GSK Investigational Site — Birmingham, Alabama
GSK Investigational Site — Los Angeles, California
GSK Investigational Site — Los Angeles, California
GSK Investigational Site — Los Angeles, California
GSK Investigational Site — Aurora, Colorado
GSK Investigational Site — Denver, Colorado
GSK Investigational Site — New Haven, Connecticut
GSK Investigational Site — Newark, Delaware
GSK Investigational Site — Washington D.C., District of Columbia
GSK Investigational Site — Jacksonville, Florida
GSK Investigational Site — Miami, Florida
GSK Investigational Site — Sarasota, Florida
GSK Investigational Site — West Palm Beach, Florida
GSK Investigational Site — Atlanta, Georgia
GSK Investigational Site — Decatur, Georgia
GSK Investigational Site — Macon, Georgia
GSK Investigational Site — Chicago, Illinois
GSK Investigational Site — Chicago, Illinois
GSK Investigational Site — Chicago, Illinois
GSK Investigational Site — Baltimore, Maryland
GSK Investigational Site — Baltimore, Maryland
GSK Investigational Site — Boston, Massachusetts
GSK Investigational Site — Berkley, Michigan
GSK Investigational Site — Kansas City, Missouri
GSK Investigational Site — St Louis, Missouri

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗