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.
Age
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.
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.
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.
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.
Parallel
CAB LA + RPV LA
DrugIntramuscular injection administered monthly for first 2 initiation doses then every 2 months.
Oral ART
DrugOral medication provided to participants by the site/their regular healthcare professional (HCP) as part of their standard of care (SOC) treatment.
Number of participants with virologic suppression after the CAB LA + RPV LA treatment compared to oral ART
A virologic suppression is defined by HIV-1 RNA less than (\<) 50 copies (c)/mL.
Time to virologic suppression
Time to treatment related discontinuation (=Failure) (TRDF)
TRDF can be caused by a confirmed virologic failure or a drug-related adverse event (AE), intolerability of injections, protocol defined stopping criteria or lack of efficacy.
Number of participants with confirmed protocol-defined virologic failure (VF)
VF is defined as: confirmed plasma HIV-1 RNA levels greater than or equal to (\>=) 400 c/mL on or after Month 4; confirmed rebound in plasma HIV-1 RNA levels to \>=400 c/mL after prior confirmed suppression to \<400 c/mL; confirmed plasma HIV-1 RNA levels greater than (\>) 1 log10 c/mL above the nadir value where nadir is \>=400 c/mL; decrease in plasma HIV-1 RNA of \<1 log10 c/mL by Month 1, with subsequent. confirmation, and resistance emergence to ARVs (unless plasma HIV-1 RNA is. \<400 c/mL).
Number of participants with treatment-emergent resistance-associated mutations (RAMs)
Click on the lead sponsor to view all of their trials.
