Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

Inclusion Criteria:

• Adult ≥ 18 years males or non-pregnant females

• Ability to understand and sign a written informed consent form

• General medical condition that does not interfere with the assessments and thecompletion of the trial

• Treatment Naive: No prior use of any approved or investigational antiretroviral drugfor any length of time OR

• Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior toscreening

• Plasma HIV-1 RNA levels ≥ 1000 copies/mL at Screening

• Screening genotype report shows full sensitivity to two nucleoside analogue reversetranscriptase inhibitors (NRTIs) and no darunavir resistance-associated mutations

• Normal electrocardiogram (ECG)

• Hepatic transaminases ≤ 2.5 × upper limit of normal (ULN)

• Total bilirubin ≤ 1.5 mg/dL

• Adequate hematologic function

• Serum amylase ≤ 2 × ULN and serum lipase ≤ 3 × ULN

• Adequate renal function: Estimated glomerular filtration rate ≥ 80 mL/min

• Females of childbearing potential must agree to utilize protocol-recommended methodsof contraception, or be nonheterosexually active, practice sexual abstinence or have avasectomized partner from Screening throughout the duration of the study period andfor 30 days following the last dose of study drug.

• Male subjects must agree to utilize protocol-recommended methods of contraceptionduring heterosexual intercourse from the Screening visit, throughout the duration ofthe study and for 30 days following discontinuation of investigational medicinalproduct or be nonheterosexually active, practice sexual abstinence, or bevasectomized.

Exclusion Criteria:

• Previous or current use of darunavir

• A new AIDS-defining condition diagnosed within the 30 days prior to Screening

• Females who are breastfeeding

• Positive serum pregnancy test (if female of childbearing potential)

• Proven or suspected acute hepatitis in the 30 days prior to study entry

• Subjects receiving drug treatment for hepatitis C virus (HCV), or subjects who areanticipated to receive treatment for HCV during the course of the study

• Have a history of ongoing active liver disease or experiencing decompensated cirrhosisirrespective of liver enzyme levels

• Have an implanted defibrillator or pacemaker

• Current alcohol or substance use that may interfere with subject study compliance

• A history of malignancy within the past 5 years or ongoing malignancy other thancutaneous Kaposi's sarcoma

• Active, serious infections requiring parenteral antibiotic or antifungal therapywithin 30 days prior to Baseline

• Participation in any other clinical trial

• Any other clinical condition or prior therapy that would make the subject unsuitablefor the study or unable to comply with the dosing requirements.

• Subjects receiving ongoing therapy with any of the medications, including drugs not tobe used with cobicistat, darunavir, or investigator selected NRTIs; or subjects withany known allergies to cobicistat tablets, darunavir tablets or contraindications forthe 2 NRTIs as part of the regimen.