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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
Intramuscular injection administered monthly for first 2 initiation doses then every 2 months.
Oral 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 frame: At Month 6
Time to virologic suppression
Time frame: From Baseline (Day 1) up to Month 6
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.
Time frame: From Baseline (Day 1) up to Month 6
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).
Time frame: From Baseline (Day 1) up to Month 6
Number of participants with treatment-emergent resistance-associated mutations (RAMs)
Time frame: From Baseline (Day 1) up to Month 6
Number of participants with treatment-emergent RAMs
Time frame: Up to Month 12 and Month 24
Number of participants with serious adverse events (SAEs)
A SAE is defined as any untoward medical occurrence that, at any dose, meets one or. more of the following criteria: results in death, is life threatening, requires inpatient hospitalization (or prolongation of existing hospitalization), results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, abnormal pregnancy outcomes and other significant medical events deemed so by the investigator.
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GSK Investigational Site
Birmingham, Alabama, United States
RECRUITINGGSK Investigational Site
Beverly Hills, California, United States
WITHDRAWNGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Aurora, Colorado, United States
RECRUITINGGSK Investigational Site
Denver, Colorado, United States
RECRUITINGGSK Investigational Site
New Haven, Connecticut, United States
RECRUITINGGSK Investigational Site
Newark, Delaware, United States
RECRUITINGGSK Investigational Site
Washington D.C., District of Columbia, United States
RECRUITING...and 79 more locations
Time frame: Up to Month 6, Month 12, and Month 24
Number of deaths
Time frame: Up to Month 6, Month 12, and Month 24
Number of participants with Grade 2 to 5 drug-related adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not. considered related to the study intervention. Every AE is graded according to the DAIDS toxicity scales. Grade 2 = moderate symptoms, Grade 3 = severe symptoms, Grade 4 = Potentially life-threatening. symptoms and Grade 5 = death.
Time frame: Up to Month 6, Month 12, and Month 24
Number of AEs leading to discontinuation
Time frame: Up to Month 6, Month 12, and Month 24