View Clinical Trial (Medical Research Study)

A Phase 3b, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir Plus Two Fully Active Nucleoside Reverse Transcriptase Inhibitors in HIV 1 Infected, Antiretroviral Treatment-Naïve and -Experienced Adults With N

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Conditions:		Acquired Immunodeficiency Syndrome - HIV Infections
Purpose:		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.
Study Summary:		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
Criteria:		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.
NCT ID:		NCT01440569
Primary Contact:		Study Director Marshall Fordyce, MD Gilead Sciences Anne Thomas Phone: 650 372-7998 Email: Anne.Thomas@gilead.com
Backup Contact:		N/A
Location Contact:		Fort Pierce, Florida 34983 United States Site Status: Recruiting

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