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)
ViiV Healthcare
Summary
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. 3.Plasma HIV-1 RNA \>1 000 c/mL and greater than (\<) 100 000 c/mL at Screening. 4.Evidence of insufficient viro…
Interventions
- DrugCAB LA + RPV LA
Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
- DrugOral ART
Oral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.
Locations (89)
- GSK Investigational SiteBirmingham, Alabama
- GSK Investigational SiteBeverly Hills, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteLos Angeles, California
- GSK Investigational SiteAurora, Colorado