Phase 3b Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
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-naive and treatment-experienced adult subjects with no Darunavir (DRV) resistance-associated mutations.
Acquired Immunodeficiency Syndrome
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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 No Darunavir Resistance-associated Mutations|
- Onset of treatment emergent Grade 3 or Grade 4 adverse events [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]The onset of any treatment emergent Grade 3 or Grade 4 adverse event through 24 weeks will be summarized.
- The proportion of participants achieving HIV RNA < 50 copies/mL at Weeks 24 and 48 [ Time Frame: Week 24 and 48 ] [ Designated as safety issue: No ]
- The change from baseline in CD4+ cell count at Weeks 24 and 48 [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Incidence of treatment emergent adverse events through 24 and 48 weeks that lead to discontinuation of study medication [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]
- Proportion of participants experiencing any treatment emergent adverse event through 24 and 48 weeks [ Time Frame: Baseline to Weeks 24 and 48 ] [ Designated as safety issue: No ]The proportion of participants experiencing any adverse event through Week 24 and Week 48 will be summarized.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Experimental: cobicistat boosted darunavir
Darunavir 800 mg (2 x 400 mg tablets) with food daily + cobicistat 150 mg tablet with food daily + two (2) Investigator-selected nucleoside reverse transcriptase inhibitors (NRTIs) selected by resistance testing at screening, administered orally
cobicistat 150 mg tablet with food daily for 48 weeks
Other Name: COBI, GS-9350Drug: Darunavir
darunavir 800 mg (2 x 400 mg tablets) with food daily for 48 weeks
Other Name: DRV, Prezista®
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|Study Director:||Marshall Fordyce, MD||Gilead Sciences|