Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

Inclusion Criteria:

Cohort 1 (Treatment Naïve)

- Plasma HIV-1 RNA levels ≥ 1,000 copies/mL at screening

- Screening genotype report must show sensitivity to FTC and TDF

- No prior use of any approved or investigational antiretroviral drug for any length of
time

Cohort 2 (Pharmacoenhancer Switch)

- Subjects must be receiving ATV 300 mg/RTV 100 mg plus 2 NRTIs OR DRV 800 mg/RTV 100
mg plus 2 NRTIs for at least 6 months prior to screening

- Plasma HIV-1 RNA concentrations at undetectable levels in the 6 months preceding the
screening visit and have HIV-1 RNA < 50 copies/mL at screening

- Subjects experiencing intolerance to RTV (as determined by the Investigator)

Cohort 1 and Cohort 2

- The ability to understand and sign a written informed consent form

- Normal ECG

- Mild to Moderate renal function

- Stable renal function

- Hepatic transaminases (AST and ALT) ≤ 5 x ULN

- Total bilirubin ≤ 1.5 mg/dL, or normal direct bilirubin (subjects with documented
Gilbert's Syndrome or hyperbilirubinemia due to atazanavir therapy may have total
bilirubin up to 5 x upper limit of normal)

- 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

Exclusion Criteria:

- New 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, non-invasive cutaneous
squamous carcinoma

- Active, serious infections (other than HIV 1 infection) requiring parenteral
antibiotic or antifungal therapy within 30 days prior to Baseline

- Receiving ongoing therapy with any of medications contraindicated for use with EVG,
COBI, FTC, TDF, ATV, DRV; or subjects with any known allergies to the excipients of
EVG/COBI/FTC/TDF STR, COBI tablets, atazanavir capsules or darunavir tablets or
contraindicated for the 2 NRTIs as part of the Cohort 2 regimen

- Participation in any other clinical trial without prior approval

- Any other clinical condition or prior therapy that would make the subject unsuitable
for the study or unable to comply with the dosing requirements