Cabotegravir and Rilpivirine Ultra Long-Acting in people with HIV who are virologically suppressed

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, interventional trial compares ultra-long-acting cabotegravir and rilpivirine with their long-acting formulations to continue viral suppression in adults and adolescents with HIV who have been on stable ART and have VL <50 copies/mL. Participants will receive injections administered on a set schedule and will be monitored for efficacy, safety, and tolerability. Eligible individuals must meet specific virologic and treatment-history criteria, including no prior virologic failure and adequate body weight, with exclusions for certain resistance profiles and recent immunotherapies. The study is sponsored by ViiV Healthcare and conducted at select investigational sites in California and Arizona.

Why it matters

Who can join: the full rules

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 treatment or prevention of HIV
* Previous exposure to injectable CAB and/or injectable 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.

Where it's running

• GSK Investigational Site
  Phoenix, Arizona, United States Recruiting
• GSK Investigational Site
  Bakersfield, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  Los Angeles, California, United States Recruiting
• GSK Investigational Site
  San Diego, California, United States Recruiting
• GSK Investigational Site
  West Hollywood, California, United States Recruiting

+61 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center
• Email: GSKClinicalSupportHD@gsk.com
• Phone: 877-379-3718

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.