Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing CAB ULA for HIV

This study compares the how well it works, whether it is safe and how hard side effects are to live with 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).

Official registry: https://clinicaltrials.gov/study/NCT07650916 · ViiV Healthcare · enrollment listed as 564

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are CAB ULA, RPV ULA, or CAB LA. The registry lists allocation as randomized. This study compares the how well it works, whether it is safe and how hard side effects are to live with 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).

They plan to enroll about 564 people at 84 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: CAB ULA, RPV ULA, CAB LA, RPV LA

Primary outcome (registry wording): Percentage of participants with plasma HIV-RNA greater than or equal to (>=) 50 copies (c)/mL as per Food and Drug Administration (FDA) Snapshot algorithm

Who it is for (from inclusion criteria)

  • Ages 12 Years to any
  • Patient Study Participant (PSP) who can join
  • 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)

Public study contact (from the registry)

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

84 listed

+ 45 sites outside the US on the same record

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NCT00039689 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)

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FAQ about this NCT record

Is NCT07650916 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07650916?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07650916?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary