A Phase 3B, Randomized, Open-label Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared with a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Na?ve Adults. - ND

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 700

Inclusion Criteria

Subjects HIV-1 infected that meet the following inclusion criteria: • Adult (= 18 years) males or non-pregnant females • Plasma HIV 1 RNA levels = 2,500 copies/mL at screening • No prior use of any approved or experimental anti-HIV drug for any length of time with the exception of PrEP (pre-exposure prophylaxis) • Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV mutations K101E/P, E138G/K/Q/R, Y181C/I/V, and H221Y • Adequate renal function: Estimated glomerular filtration rate = 50 mL/min according to the Cockcroft Gault formula.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects who meet any of the following exclusion criteria: • A new AIDS defining condition diagnosed within the 30 days prior to screening • Acute hepatitis • Subjects receiving drug treatment for Hepatitis C • Subjects experiencing decompensated cirrhosis • A history of malignancy within the past 5 years (prior to screening) or ongoing malignancy • Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungals therapy • Have a history of liver disease, including Gilbert’s Disease • Subjects receiving ongoing therapy or anticipated to need to initiate drugs during the study that are contraindicated.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of a single tablet regimen of emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) compared with a single tablet regimen of efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF, [Atripla]) in HIV-1 infected, antiretroviral treatment-na?ve adult subjects as determined by the achievement HIV-1 RNA < 50 copies/mL at 48 weeks; FDA snapshot analysis.;Secondary Objective: • To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment • To assess change from baseline CD4 count in each treatment arm at 48 & 96 weeks • To assess genotypic and phenotypic resistance at time of virologic failure • To evaluate the change from baseline in fasting lipid parameters (total cholesterol, LDL and HDL cholesterol, triglycerides) at 48 & 96 weeks.;Primary end point(s): The primary efficacy endpoint is the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 48 as defined by the FDA snapshot analysis.

Secondary Outcome Measures