A Phase 4 Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Oral B/F/TAF After Discontinuing Injectable CAB + RPV

GS-US-380-6738

The goal of this clinical study is to learn how safe and effective it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels. The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.

2023-12-13

2024-11-01

2025-05-01

Recruiting

Early phase I

35

Key Inclusion Criteria: * People with HIV-1 (PWH) or provider decision to switch off CAB+RPV IM injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily B/F/TAF * Currently virologically suppressed (HIV-1 RNA \< 50 copies/mL) on CAB+RPV IM injections every 2 months * Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections * Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV * Documented plasma HIV-1 RNA \< 50 copies/mL during treatment for ≥ 6 months preceding the screening visit * No documented or suspected resistance to BIC, emtricitabine (FTC), or tenofovir (TFV). Key Exclusion Criteria: * History of B/F/TAF intolerance * History of previous INSTI virologic failure including CAB+RPV * Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug * Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies) * Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1 Note: Other protocol defined Inclusion/Exclusion criteria may apply.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 35, 'type': 'ESTIMATED'}}

2024-04-29