A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide Versus Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate in HIV 1 Positive, Antiretroviral Treatment- Naive Adults
Phase 3
- Conditions
- HIV-1 infection
- Registration Number
- JPRN-jRCT2080222080
- Lead Sponsor
- JAPAN TABACCO INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 840
Inclusion Criteria
Plasma HIV-1 RNA level is 1,000 copies/mL or above at screening
Screening genotype report demonstrating sensitivity to EVG, FTC, and TDF
Estimated glomerular filtration rate is 50 mL/min or above according to the Cockcroft-Gault formula for creatinine clearance
Exclusion Criteria
A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening
Hepatitis B surface antigen (HBsAg) positive
Hepatitis C antibody positive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method