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 January 2013
End date September 2014
Trial size 872 participants
Trial identifier NCT01797445, 2013-000102-37, GS-US-292-0111

Summary

This study will evaluate the efficacy and safety 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.

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 plus placebo to match E/C/F/TDF for 144 weeks
e/c/f/taf
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) single-tablet regimen administered orally once daily
placebo to match e/c/f/tdf
Placebo to match E/C/F/TDF administered orally once daily
(Active Comparator)
E/C/F/TDF plus placebo to match E/C/F/TAF for 144 weeks
e/c/f/tdf Stribild®
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg (E/C/F/TDF) single-tablet regimen administered orally once daily
placebo to match e/c/f/taf
Placebo to match E/C/F/TAF administered orally once daily

Primary Outcomes

Measure
The 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: Baseline; Week 48
Percent change from baseline in spine BMD
time frame: Baseline; Week 48
Change from baseline in serum creatinine at Week 48
time frame: Baseline; Week 48
Incidence of treatment-emergent proteinuria through Week 48
time frame: Up to 48 weeks
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 96 and 144
time frame: Weeks 96 and 144
Proportion of participants with HIV-1 RNA < 20 copies/mL
time frame: Weeks 48, 96, and 144
Change from baseline in CD4+ cell count
time frame: Baseline; Weeks 48, 96, and 144
Percent change from baseline in hip and spine BMD at Weeks 96 and 144
time frame: Baseline; Weeks 96 and 144
Change from baseline in serum creatinine at Weeks 96 and 144
time frame: Baseline; Weeks 96 and 144
Incidence of treatment-emergent proteinuria
time frame: Up to 144 weeks
Urine retinol binding protein (RBP) to creatinine ratio
time frame: Weeks 48, 96, and 144
Urine beta-2-microglobulin to creatinine ratio
time frame: Weeks 48, 96, and 144

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), or post-exposure prophylaxis (PEP) up to 6 months prior to screening - Screening genotype report must show sensitivity to elvitegravir, emtricitabine, 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 - Males 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 - Females 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 - Females 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 - Individuals 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 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 individual unsuitable for the study or unable to comply with dosing requirements - Participation in any other clinical trial (including observational trials) without prior approval - Receiving ongoing therapy with drugs not to be used with elvitegravir, cobicistat, emtricitabine, tenofovir DF, and TAF or participants 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 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.