A Phase 3, double-blind study, evaluate the safety and efficacy of Bictegravir/Emtricitabine/Tenofovir Alafenamide in HIV-1 and Hepatitis B Co-Infected Adults
- Conditions
- HIV-1/HBV Co-Infection
- Registration Number
- JPRN-jRCT2080224956
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 240
Key Inclusion Criteria:
HIV-1 co-infection:
-Must be HIV antiretroviral treatment naive with plasma HIV-1 RNA > 500 copies/mL at screening
HBV co-infection:
-Screening HBV DNA > 2000 IU/m
Key Exclusion Criteria:
-HCV antibody positive and HCV RNA detectable
-Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding) or with Child-Pugh-Turcotte C impairment
-Current alcohol or substance use judged by the Investigator to potentially interfere with study compliance
-Active, serious infections (other than HIV-1 and HBV infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
-Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>confirmatory<br>-Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm [ Time Frame: Week 48 ]<br>-Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 48 as Defined by Missing = Failure Approach [ Time Frame: Week 48 ]
- Secondary Outcome Measures
Name Time Method efficacy<br>-Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 96 as Defined by the US FDA-Defined Snapshot Algorithm<br>-Change from Baseline in CD4 Cell Count and CD4 Percentage at Week 48 and Week 96<br>-Proportion of Participants With Plasma HBV DNA < 29 IU/mL at Week 96 <br>-Proportion of Participants With Alanine Aminotransferase Normalization at Week 48 and Week 96<br>-Proportion of Participants With Hepatitis B Surface Antigen (HBsAg) Loss at Week 48 and Week 96