Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: E/C/F/TDF; ATV; RTV; FTC/TDF; E/C/F/TDF Placebo; ATV Placebo; RTV Placebo; FTC/TDF Placebo; E/C/F/TAF
Intervention description: 150/150/200/300 mg FDC tablet administered orally with food once daily; 300 mg capsule administered orally with food once daily; 100 mg tablet administered orally with food once daily; 200/300 mg tablet administered orally with food once daily; Tablet administered orally with food once daily; Tablet administered orally with food once daily; Capsule administered orally with food once daily; Tablet administered orally with food once daily; 150/150/200/10 mg FDC tablet administered orally with food once daily
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 583.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment-Naive; Women; WAVES

Summary:

      The primary objective of this study is to evaluate the efficacy of a regimen containing
      elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus
      ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate
      (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Female (at birth), age ≥ 18 years

          -  Ability to understand and sign a written informed consent form

          -  Plasma HIV-1 RNA levels ≥ 500 copies/mL

          -  No prior use of any approved or investigational antiretroviral drug for any length of
             time

          -  Screening genotype report must show sensitivity to emtricitabine (FTC), tenofovir
             disoproxil fumarate (TDF) and atazanavir (ATV) boosted with ritonavir (RTV)

          -  Normal ECG

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to
             the Cockcroft Gault formula

          -  Hepatic transaminases ≤ 5 x upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Adequate hematologic function

          -  Serum amylase ≤ 5 x ULN

          -  Women of childbearing potential must agree to utilize protocol recommended
             contraception methods or be non-heterosexually active, or practice sexual abstinence
             from screening throughout the duration of the study period and for 30 days following
             the last dose of study drug

          -  Women 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.

        Key Exclusion Criteria:

          -  A new AIDS defining condition diagnosed within the 30 days

          -  Females receiving drug treatment for Hepatitis C, or females who are anticipated to
             receive treatment for Hepatitis C during the course of the study

          -  Females experiencing decompensated cirrhosis

          -  Females who are breastfeeding

          -  Positive serum pregnancy test (female of childbearing potential)

          -  Have an implanted defibrillator or pacemaker

          -  Have an ECG pulse rate interval ≥ 220 msec

          -  Current alcohol or substance use which may potentially interfere with the female's
             study compliance

          -  History of malignancy within the past 5 years or ongoing malignancy other than
             cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive
             cutaneous squamous carcinoma

          -  Active, serious infections requiring parenteral antibiotic or antifungal therapy
             within 30 days prior to baseline

          -  Participation in any other clinical trial without prior approval

          -  Any other clinical condition or prior therapy that would make the female unsuitable
             for the study or unable to comply with the dosing requirements

          -  Females receiving ongoing therapy with any disallowed medications, including drugs not
             to be used with elvitegravir, cobicistat, FTC, TDF, ATV, RTV; or females with any
             known allergies to the excipients of Stribild® tablets, Truvada® tablets, atazanavir
             capsules or ritonavir tablets

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.