Overview

This trial is active, not recruiting.

Conditions hiv, hiv infections
Treatments stribild, atv/r + truvada
Phase phase 3
Sponsor Gilead Sciences
Start date April 2010
End date September 2011
Trial size 708 participants
Trial identifier NCT01106586, GS-US-236-0103

Summary

To evaluate the safety and efficacy of Stribild, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/GS-9350 (cobicistat; COBI)/emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) versus ritonavir-boosted atazanavir (ATV/r) plus the standard of care nucleoside reverse transcriptase inhibitor (NRTI) backbone FTC/TDF (Truvada). Ritonavir-boosted atazanavir + Truvada was selected as the active comparator for this study as it is a preferred protease inhibitor-based regimen in guidelines for the treatment of HIV-1 infected, 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)
stribild
Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR + placebos to match ritonavir-boosted atazanavir (ATV/r) and Truvada once daily (QD)
(Active Comparator)
atv/r + truvada
Atazanavir 300 mg/Ritonavir 100 mg (ATV/r) and FTC 200 mg/TDF 300 mg (Truvada) + placebo to match Stribild STR QD

Primary Outcomes

Measure
The Percentage of Participants With Virologic Success Using the Food and Drug Administration (FDA)-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 Ribonucleic Acid (RNA) < 50 Copies/mL
time frame: Week 48

Secondary Outcomes

Measure
The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm
time frame: Week 48
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Week 48
time frame: Baseline to Week 48
The Percentage of Participants With HIV-1 RNA < 50 Copies/mL
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 - Plasma HIV-1 RNA levels ≥ 5,000 copies/mL at screening - No prior use of any approved or investigational antiretroviral drug for any length of time - Screening genotype report must show sensitivity to FTC, TDF, and ATV - Normal electrocardiogram (ECG) - Adequate renal function (estimated glomerular filtration rate ≥ 70 mL/min according to the Cockcroft Gault formula) - Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) ≤ 5 x the upper limit of the normal range (ULN) - Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin - Adequate hematologic function - Serum amylase ≤ 5 x ULN - Males and Females of childbearing potential must agree to utilize highly effective contraception methods from screening throughout the duration of study treatment and for 30 days following the last dose of study drug - Age ≥ 18 years - Life expectancy ≥ 1 year Exclusion Criteria: - A new acquired immunodeficiency syndrome (AIDS) defining condition diagnosed within the 30 days prior to screening - Receiving drug treatment for hepatitis C, or anticipated to receive treatment for hepatitis C - Subjects experiencing decompensated cirrhosis - Females who are breastfeeding - Positive serum pregnancy test (female of childbearing potential) - Implanted defibrillator or pacemaker - Have an ECG PR interval ≥ 220 msec - 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 - Medications contraindicated for use with EVG, COBI, FTC, TDF, ATV, or ritonavir or subjects with any known allergies to the excipients of Stribild tablets, Truvada tablets, ATV capsules or ritonavir tablets - Participation in any other clinical trial without prior approval - 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 the dosing requirements

Additional Information

Official title A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Elvitegravir/Emtricitabine/Tenofovir Disoproxil Fumarate/GS-9350 Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Gilead Sciences.