Overview

This trial is active, not recruiting.

Conditions hiv, hiv infections
Treatments e/c/f/taf, e/c/f/tdf, efv/ftc/tdf, rtv, atv, ftc/tdf, cobi
Phase phase 3
Sponsor Gilead Sciences
Start date March 2013
End date March 2015
Trial size 1439 participants
Trial identifier NCT01815736, 2012-005114-20, GS-US-292-0109

Summary

This randomized, open-label, active-controlled study is to evaluate the non-inferiority of switching to a tenofovir alafenamide (TAF)-Containing Combination single tablet regimen (STR) relative to maintaining tenofovir disoproxil fumarate (TDF)-containing combination regimens in virologically-suppressed HIV-1 positive subjects as determined by having HIV-1 RNA < 50 copies/mL at Week 48 following the switch.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will switch to STR of E/C/F/TAF for 48 weeks.
e/c/f/taf
Single-tablet regimen of elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (E/C/F/TAF) administered orally once daily
(Active Comparator)
Participants will maintain their pre-existing regimen of E/C/F/TDF, EFV/FTC/TDF, RTV+ATV+FTC/TDF, or COBI+ATV+FTC/TDF for 48 weeks.
e/c/f/tdf Stribild® (E/C/F/TDF)
Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (E/C/F/TDF) tablets administered orally once daily
efv/ftc/tdf Atripla® (EFV/FTC/TDF)
Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF) tablets administered orally once daily
rtv
Ritonavir (RTV) 100 mg tablets administered orally once daily
atv
Atazanavir (ATV) 300 mg capsules administered orally once daily
ftc/tdf Truvada® (FTC/TDF)
Emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) tablets administered orally once daily
cobi Tybost®
Cobicistat (COBI) 150 mg tablets administered orally once daily

Primary Outcomes

Measure
The proportion of participants who have HIV-1 RNA < 50 copies/mL at Week 48
time frame: Week 48

Secondary Outcomes

Measure
Percent change from baseline in hip bone mineral density
time frame: Week 48
Percent change from baseline in spine bone mineral density
time frame: Week 48
Change from baseline in serum creatinine
time frame: Week 48
Change from baseline in efavirenz-related symptom assessment score
time frame: Week 48

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 - Currently receiving antiretroviral therapy consisting of E/C/F/TDF, EFV/FTC/TDF, ATV/r + FTC/TDF, or ATV/co + FTC/TDF for ≥ 6 consecutive months preceding the final visit in their earlier study - Completion of the Week 144 visit in studies GS-US-236-0102, GS-US-236-0103, GS-US-216-0114, or completion of the Week 96 visit in study GS-US-264-0110 (only subjects on an efavirenz-based regimen), or completion of studies GS-US-236-0104, GS-US-216-0105 - Plasma HIV-1 RNA concentrations at undetectable levels for at least 6 consecutive months prior to the screening visit and have HIV RNA <50 copies/mL at the screening visit - Normal echocardiograph (ECG) - Estimated glomerular filtration rate (GFR) ≥ 50 mL/min according to the Cockcroft-Gault formula for creatinine clearance - Hepatic transaminases (AST and ALT) ≤ 5 × upper limit of the normal range (ULN) - Direct bilirubin ≤ 1.5 mg/dL - Adequate hematologic function - Serum amylase ≤ 5 × ULN - 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 AIDS-defining condition diagnosed within the 30 days prior to screening - Hepatitis B surface antigen position - 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 without prior approval from the sponsor is prohibited while participating in this trial - Subjects receiving ongoing therapy with drugs not to be used with elvitegravir (EVG), cobicistat (COBI), FTC, TDF, ATV, ritonavir (RTV), EFV, and TAF or subjects with any known allergies to the excipients of E/C/F/TDF STR, E/C/F/TAF STR, EFV/FTC/TDF, ATV, COBI, RTV, or FTC/TDF

Additional Information

Official title A Phase 3, Open-Label Study to Evaluate Switching From a TDF-containing Combination Regimens to a TAF-Containing Combination Single Tablet Regimen (STR) in Virologically-suppressed, HIV-1 Positive Subjects
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Gilead Sciences.