A Study to Investigate Cabotegravir Ultra Long-Acting (CAB ULA) Plus Rilpivirine Ultra Long-Acting (RPV ULA) in Adults and Adolescents With HIV Who Are Virologically Suppressed
Purpose
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).
Condition
- HIV Infections
Eligibility
- Eligible Ages
- Over 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
Patient Study Participant (PSP) Inclusion criteria: - 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).
Exclusion Criteria
Patient Study Participant (PSP) Exclusion criteria: - Any evidence of primary resistance based on the presence of any major known INSTI (including CAB) or NNRTI (including RPV) resistance-associated mutation. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening. - Any history of receiving long-acting therapy for HIV. - Previous exposure to CAB and/or RPV for treatment or prevention of HIV-1 infection. - Significant uncontrolled or clinically relevant comorbidities (e.g., cardiovascular, hepatic, renal, neurological, psychiatric) that may impact safety or study participation. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
- Masking Description
- This is an open-label study.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CAB ULA+ RPV ULA |
Participants will receive CAB ULA+RPV ULA. |
|
|
Active Comparator CAB LA+ RPV LA |
Participants will receive CAB LA+RPV LA. |
|
Recruiting Locations
Phoenix, Arizona 85015
Bakersfield, California 93301
Los Angeles, California 90027
Los Angeles, California 90036
San Diego, California 92103
New Haven, Connecticut 06510
Washington D.C., District of Columbia 20017
DeLand, Florida 32720
Fort Lauderdale, Florida 33316
Ft. Pierce, Florida 34982
Miami, Florida 33136
Orlando, Florida 32803
Pensacola, Florida 32503
Vero Beach, Florida 32960
West Palm Beach, Florida 33407
West Palm Beach, Florida 33409
Decatur, Georgia 30033
Grosse Pointe Woods, Michigan 48236
Kansas City, Missouri 64111
Las Vegas, Nevada 89101
Newark, New Jersey 07102
Santa Fe, New Mexico 87505
Stony Brook, New York 11794
Syracuse, New York 13057
Greensboro, North Carolina 27401
Columbus, Ohio 43210
Philadelphia, Pennsylvania 19104
Austin, Texas 78705
Dallas, Texas 75219
Dallas, Texas 75246
El Paso, Texas 79902
Houston, Texas 77098
Salt Lake City, Utah 84102
Lynchburg, Virginia 24501
Seattle, Washington 98104
San Juan, Puerto Rico 00909
More Details
- Status
- Recruiting
- Sponsor
- ViiV Healthcare