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
Condition: HIV; HIV Infections
MeSH terms: HIV Infections
Intervention: Stribild; ATV; Ritonavir; FTC/TDF; Stribild Placebo; ATV Placebo; RTV Placebo; FTC/TDF Placebo
Intervention description: Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily; Atazanavir 300 mg capsule administered orally once daily; Ritonavir (RTV; /r) 100 mg tablet administered orally once daily; FTC/TDF 200/300 mg tablet administered orally once daily; Placebo to match Stribild administered orally once daily; Placebo to match ATV administered orally once daily; Placebo to match RTV administered orally once daily; Placebo to match FTC/TDF administered orally once daily
Intervention MeSH terms: Ritonavir; Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 708.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV 1 Infection; Treatment Naive

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.
    

Eligibility criteria:

        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