Phase 3b Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults

• The proportion of subjects achieving HIV 1 RNA < 50 copies/mL [ Time Frame: 24 & 48 Weeks ] [ Designated as safety issue: No ]
  The proportion of subjects achieving HIV 1 RNA < 50 copies/mL at Weeks 24 and 48.
• The change from baseline in CD4+ cell count [ Time Frame: 24 & 48 Weeks ] [ Designated as safety issue: No ]
  The change from baseline in CD4+ cell count at Weeks 24 and 48.

The purpose of this study is to evaluate the safety and tolerability of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naïve and -experienced adult subjects with no Darunavir (DRV) resistance-associated mutations.

Open-label, single arm, multicenter, study to evaluate the safety and efficacy of a regimen of cobicistat-boosted darunavir plus two fully active nucleoside analogue reverse transcriptase inhibitors in HIV 1 infected, antiretroviral treatment-naïve and -experienced adult subjects with no DRV resistance-associated mutations

• Acquired Immunodeficiency Syndrome
• HIV Infections

• Drug: Cobicistat
  cobicistat 150 mg tablet with food daily for 48 weeks
  Other Name: COBI, GS-9350
• Drug: Darunavir
  darunavir 800 mg (2 x 400 mg tablets) with food daily for 48 weeks
  Other Name: DRV, Prezista®

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 the completion of the trial
• Treatment Naïve: No prior use of any approved or investigational antiretroviral drug for any length of time OR
• Treatment Experienced: Stable antiretroviral regimen for at least 12 weeks prior to screening
• Plasma HIV 1 RNA levels ≥ 500 copies/mL at screening
• Screening genotype report shows full sensitivity to two nucleoside analogue reverse transcriptase 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 methods of contraception, or be non heterosexually active, practice sexual abstinence or have a vasectomized partner) from screening throughout the duration of the study period and for 30 days following the last dose of study drug.
• Male subjects must agree to utilize protocol-recommended methods of contraception during heterosexual intercourse from the screening visit, throughout the duration of the study and for 30 days following discontinuation of investigational medicinal product or be non-heterosexually active, practice sexual abstinence, or be vasectomized.

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, or subjects who are anticipated to receive treatment for Hepatitis C during the course of the study
• Have a history of ongoing active liver disease or experiencing decompensated cirrhosis irrespective 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 than cutaneous Kaposi's sarcoma
• Active, serious infections requiring parenteral antibiotic or antifungal therapy within 30 days prior to Baseline
• Participation in any other clinical trial
• Any other clinical condition or prior therapy that would make the subject unsuitable for the study or unable to comply with the dosing requirements.
• Subjects receiving ongoing therapy with any of the medications, including drugs not to be used with cobicistat, darunavir, or investigator selected NRTIs; or subjects with any known allergies to cobicistat tablets, darunavir tablets or contraindications for the 2 NRTIs as part of the regimen.