This study compares the efficacy, safety and tolerability 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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
564
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
Time frame: At Month 11
Percentage of participants with plasma HIV-RNA >= 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 23
Percentage of participants with plasma HIV-RNA less than (<) 50 c/mL as per FDA Snapshot algorithm
Time frame: At Month 11 and Month 23
Percentage of participants with confirmed virologic failure (CVF)
CVF is defined as 2 consecutive HIV-1 RNA levels \>=200 c/mL.
Time frame: Up to Month 23
Number of participants with drug-related adverse events (AEs) as per severity of Grade 2-5
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. Severity is graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 2 = moderate, Grade 3 = severe, Grade 4 = potentially life-threatening, Grade 5 = death.
Time frame: Up to Month 23
Number of participants with drug-related serious adverse events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongs existing hospitalization, results in disability/incapacity or other medically significant events.
Time frame: Up to Month 23
Number of participants who discontinue treatment due to AEs or injection intolerability
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RPV LA will be administered.
GSK Investigational Site
Phoenix, Arizona, United States
RECRUITINGGSK Investigational Site
Bakersfield, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
Los Angeles, California, United States
RECRUITINGGSK Investigational Site
San Diego, California, United States
RECRUITINGGSK Investigational Site
New Haven, Connecticut, United States
RECRUITINGGSK Investigational Site
Washington D.C., District of Columbia, United States
RECRUITINGGSK Investigational Site
DeLand, Florida, United States
RECRUITINGGSK Investigational Site
Fort Lauderdale, Florida, United States
RECRUITINGGSK Investigational Site
Ft. Pierce, Florida, United States
RECRUITING...and 78 more locations
Time frame: Up to Month 23
Number of participants with treatment emergent genotypic or phenotypic resistance to CAB and RPV
Time frame: Up to Month 23
Ctrough of CAB and RPV
Time frame: Up to Month 23
Maximum concentrations post dose (Cmax) of CAB and RPV
Time frame: Up to Month 23
Area under the curve (AUC) of CAB and RPV
Time frame: Up to Month 23
Absolute value of CD4+ cell counts in participants
Time frame: Up to Month 23
Change from Baseline in CD4+ cell counts in participants
Time frame: At Month 23 compared to baseline (Day 1)