Study to Evaluate the Safety and Efficacy of Stribild Versus Ritonavir-Boosted Atazanavir Plus Truvada in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults

Phase 3

Completed

Interventions: Drug: Stribild
Drug: ATV
Drug: ATV Placebo
Drug: Ritonavir
Drug: RTV Placebo
Drug: FTC/TDF
Drug: FTC/TDF Placebo
Drug: Stribild Placebo

Brief Summary: To evaluate the safety and efficacy of Stribild®, a single tablet regimen (STR) containing fixed doses of elvitegravir (EVG)/cobicistat (COBI \[GS-9350\])/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®). ATV/r + FTC/TDF 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.

Recruitment & Eligibility

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
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

Arm && Interventions

Primary Outcome Measures

Name	Time	Method
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 at Week 48	Week 48

Secondary Outcome Measures

Name	Time	Method
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 144	Week 144
The Change From Baseline in Cluster Determinant 4 (CD4) Cell Count at Weeks 48, 96, 144, and 192	Baseline; Weeks 48, 96, 144, and 192	Change = value of the relevant time point minus the baseline value
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 96	Week 96
The Percentage of Participants Achieving and Maintaining Confirmed HIV-1 RNA < 50 Copies/mL at Week 48 Using the FDA-defined Time to Loss of Virologic Response (TLOVR) Algorithm	Week 48
The Percentage of Participants With Virologic Success Using the FDA-Defined Snapshot Analysis as Determined by the Achievement of HIV-1 RNA < 50 Copies/mL at Week 192	Week 192
The Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	Week 48

Locations (146): Spectrum Medical Group
🇺🇸
Phoenix, Arizona, United States
Health for Life Clinic PLLC
🇺🇸
Little Rock, Arkansas, United States
AHF Research Center
🇺🇸
Beverly Hills, California, United States
CSI Clinical Trials, Inc.
🇺🇸
Costa Mesa, California, United States
Apex Research, LLC
🇺🇸
Denver, California, United States
Kaiser Permanente Hospital
🇺🇸
Hayward, California, United States
Living Hope Clinical Foundation
🇺🇸
Long Beach, California, United States
Kaiser Permanente
🇺🇸
Los Angeles, California, United States
Los Angeles Gay and Lesbian Center DBA Jeffrey Goodman Special Care Clinic
🇺🇸
Los Angeles, California, United States
Peter J Ruane, MD, Inc
🇺🇸
Los Angeles, California, United States
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Spectrum Medical Group
🇺🇸Phoenix, Arizona, United States