D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults
Condition: Acquired Immunodeficiency Syndrome; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Intervention: D/C/F/TAF; DRV; COBI; FTC/TDF; D/C/F/TAF Placebo; DRV Placebo; COBI Placebo; FTC/TDF Placebo
Intervention description: DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily; DRV 800 mg (2 × 400 mg tablets) administered orally once daily; COBI 150 mg tablet administered orally once daily; FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily; D/C/F/TAF placebo tablet administered orally once daily; DRV placebo tablet administered orally once daily; COBI placebo tablet administered orally once daily; FTC/TDF placebo tablet administered orally once daily
Intervention MeSH terms: Darunavir; Cobicistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment-Naive

Summary:

      This study is to evaluate the safety and efficacy
      darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) fixed dose combination
      (FDC) tablet versus darunavir (DRV)+cobicistat (COBI)+emtricitabine (FTC)/tenofovir
      disoproxil fumarate (TDF) in HIV-1 infected, antiretroviral treatment-naive adults as
      determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 18 years) males or non-pregnant females

          -  Ability to understand and sign a written informed consent form

          -  General medical condition which does not interfere with the assessments and the
             completion of the trial

          -  Plasma HIV-1 RNA levels ≥ 5,000 copies/mL

          -  CD4+ cell count > 50 cells/µL

          -  Treatment-naive: No prior use of any approved or experimental anti-HIV drug for any
             length of time

          -  Screening genotype report must show sensitivity to DRV, TDF and FTC

          -  Normal ECG

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 70 mL/min according to
             the Cockcroft Gault formula

          -  Hepatic transaminases ≤ 2.5 x upper limit of normal (ULN)

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Serum amylase ≤ 5 x ULN

          -  Adequate hematologic function

          -  Normal thyroid-stimulating hormone (TSH)

          -  Females of childbearing potential must have a negative serum pregnancy test

          -  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 drugs

          -  Female subjects who are postmenopausal must have documentation of cessation of menses
             for ≥ 12 months and hormonal failure

          -  Female subjects who have stopped menstruating for ≥ 12 months but do not have
             documentation of ovarian hormonal failure must have a serum follicle stimulating
             hormone (FSH) level test

          -  Male subjects must agree to utilize a highly effective method of contraception during
             heterosexual intercourse throughout the study period and for 90 days following
             discontinuation of investigational medicinal product

        Exclusion Criteria:

          -  A new AIDS defining condition diagnosed within the 30 days prior to screening

          -  Hepatitis B surface antigen positive

          -  Hepatitis C antibody positive

          -  Proven acute hepatitis in the 30 days prior to study entry

          -  Have a history or experiencing decompensated cirrhosis

          -  Current alcohol or substance use that potentially interferes with study compliance

          -  Any other clinical condition or prior therapy that would make the subject unsuitable
             for the study or unable to comply with the dosing requirements

          -  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

          -  Females who are breastfeeding

          -  Positive serum pregnancy test (female of childbearing potential)

          -  Female subjects who utilize non-estrogen hormonal contraceptive as one of their birth
             control methods must have used the same method for at least three months prior to
             study dosing

          -  Have an implanted defibrillator or pacemaker

          -  Active, serious infections (other than HIV-1 infection) requiring parenteral
             antibiotic or antifungal therapy within 30 days prior to Baseline

          -  Participation in any other clinical trial without prior approval is prohibited while
             participating in this trial

          -  Receiving ongoing therapy with any of the disallowed medications, including drugs not
             to be used with darunavir and cobicistat

          -  Note: darunavir is a sulfonamide. Participants who previously experienced a
             sulfonamide allergy will be allowed to enter the trial. To date, no potential for
             cross sensitivity between drugs in the sulfonamide class and darunavir has been
             identified in patients participating in Phase 2 and Phase 3 trials.