Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Condition: HIV-1 Infection
Intervention: FTC/RPV/TDF; EFV/FTC/TDF
Intervention description: Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal; Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime
Intervention MeSH terms: Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Emtricitabine, Rilpivirine, Tenofovir Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 799.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV; HIV-1; Antiretroviral Treatment-Naïve

Summary:

      The purpose of the study was to evaluate the safety and efficacy of the emtricitabine
      (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR)
      compared with the efavirenz (EFV)/FTC/TDF STR in HIV-1 infected adults who had not previously
      received treatment with antiretroviral medications.

      Participants were randomized in a 1:1 ratio to receive one of the study treatments.
      Randomization was stratified by HIV-1 RNA level (≤ 100,000 copies/mL or > 100,000 copies/mL)
      at screening. A treatment duration of 96 weeks was planned, with the option for subjects in
      FTC/RPV/TDF STR arm to receive treatment following the Week 96 visit until FTC/RPV/TDF STR is
      commercially available or until Gilead Sciences elects to terminate development in that
      country.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and sign a written informed consent form

          -  Plasma HIV-1 RNA levels ≥ 2,500 copies/mL at screening

          -  No prior use of any approved or experimental anti-HIV drug for any length of time

          -  Screening genotype report showing sensitivity to EFV, FTC, TDF, and lack of the RPV
             mutations K101E/P, E138A/G/K/Q/R, Y181C/I/V, and H221Y

          -  Normal ECG

          -  Hepatic transaminases (alanine aminotransferase [ALT] and aspartate aminotransferase
             [AST]) ≤ 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 (participants with serum amylase > 5 x ULN remained eligible
             if serum lipase was ≤ 5 x ULN)

          -  Adequate renal function

          -  Males and Females of childbearing potential must have agreed to utilize highly
             effective contraception methods (two separate forms of contraception, one of which
             must be an effective barrier method, or be non-heterosexually active, practice sexual
             abstinence or have a vasectomized partner) from screening throughout the duration of
             study period and for 12 weeks following the last dose of study drug.

          -  Adult (≥ 18 years) males or non-pregnant females

        Exclusion Criteria:

          -  A new AIDS-defining condition diagnosed within the 30 days prior to screening

          -  Females who were breastfeeding

          -  Positive serum pregnancy test (female of childbearing potential)

          -  Proven or suspected acute hepatitis in the 30 days prior to study entry

          -  Subjects receiving drug treatment for hepatitis C, or subjects who were anticipated to
             receive treatment for hepatitis C during the course of the study

          -  Subjects experiencing decompensated cirrhosis

          -  Had an implanted defibrillator or pacemaker

          -  Current alcohol or substance abuse

          -  A history of malignancy within the past 5 years or ongoing malignancy other than
             cutaneous Kaposi's sarcoma, 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

          -  Receiving ongoing therapy or anticipated to need to initiate drugs or herbal/natural
             supplements during the study that are contraindicated or not recommended for use,
             including drugs not to be used with FTC, EFV, RPV, or TDF; or subjects with known
             allergies to the excipients of the FTC/RPV/TDF or EFV/FTC/TDF single-tablet regimens

          -  Participation in any other clinical trial without prior approval from the sponsor was
             prohibited while participating in this trial.

          -  Had been treated with immunosuppressant therapies or chemotherapeutic agents within 3
             months of study screening, or expected to receive these agents or systemic steroids
             for immunosuppression during the study (eg, corticosteroids, immunoglobulins, and
             other immune-based or cytokine-based therapies)

          -  Had any other clinical condition or prior therapy that, in the opinion of the
             Investigator, would have made the participant unsuitable for the study or unable to
             comply with the dosing requirements