Overview

This trial is active, not recruiting.

Conditions hiv, hiv infections
Treatments e/c/f/taf, e/c/f/tdf, placebo to match e/c/f/tdf, placebo to match e/c/f/taf
Phase phase 3
Sponsor Gilead Sciences
Start date December 2012
End date September 2014
Trial size 840 participants
Trial identifier NCT01780506, 2012-004458-27, GS-US-292-0104

Summary

This study is to evaluate the efficacy of a single-tablet regimen (STR)containing elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STR containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) in HIV-1 positive, antiretroviral treatment-naive adults as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
E/C/F/TAF single-tablet regimen (STR) plus placebo to match E/C/F/TDF for 96 weeks
e/c/f/taf
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally once daily
placebo to match e/c/f/tdf
Placebo to match E/C/F/TDF tablets administered orally once daily
(Active Comparator)
E/C/F/TDF STR plus placebo to match E/C/F/TAF for 96 weeks
e/c/f/tdf Stribild®
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) administered orally once daily
placebo to match e/c/f/taf
Placebo to match E/C/F/TAF tablets administered orally once daily

Primary Outcomes

Measure
Proportion of participants achieving HIV-1 RNA < 50 copies/mL
time frame: Week 48

Secondary Outcomes

Measure
Percent change from baseline in hip bone mineral density (BMD)
time frame: Week 48
Percent change from baseline in spine BMD
time frame: Week 48
Change from baseline in serum creatinine at Week 48
time frame: Week 48
Incidence of treatment-emergent proteinuria
time frame: Baseline to Week 48
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96
time frame: Week 96
Proportion of participants with HIV-1 RNA < 20 copies/mL
time frame: Weeks 48 and 96
Change from baseline in CD4+ cell count
time frame: Weeks 48 and 96
Percent change from baseline in hip and spine BMD at Week 96
time frame: Week 96
Change from baseline in serum creatinine at Week 96
time frame: Week 96
Incidence of treatment-emergent proteinuria through Week 96
time frame: Baseline to Week 96
Urine retinol binding protein (RBP) to creatinine ratio
time frame: Weeks 48 and 96
Urine beta-2-microglobulin to creatinine ratio
time frame: Weeks 48 and 96

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures - Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening - No prior use of any approved or investigational antiretroviral drug for any length of time, except the use for pre-exposure prophylaxis (PREP), post-exposure prophylaxis (PEP), or treatment during pregnancy, up to 6 months prior to screening - Screening genotype report must show sensitivity to elvitegravir, emtricitabine, tenofovir disoproxil fumarate (tenofovir DF) - Normal electrocardiogram (ECG) - Estimated glomerular filtration rate (eGFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of normal (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ≤ 5 × ULN - Male subjects and females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually active or practice sexual abstinence from screening throughout the duration of study treatment and for 30 days following the last dose of study drug - Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least three months prior to study dosing - Female subjects who have stopped menstruating for ≥ 12 months but do not have documentation of ovarian hormonal failure must have a serum follicle stimulating hormone (FSH) level at screening within the post-menopausal range based on the Central Laboratory reference range - Age ≥ 18 years 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 - Subjects experiencing decompensated cirrhosis - Females who are breastfeeding - Positive serum pregnancy test - Have an implanted defibrillator or pacemaker - Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance - History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, noninvasive cutaneous squamous carcinoma - Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to baseline - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial (including observational trials) without prior approval - Subjects receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF or E/C/F/TAF single-tablet regimen tablets

Additional Information

Official title 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-Naïve Adults
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.