D/C/F/TAF Versus COBI-boosted DRV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment Naive Adults

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.