Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
|ClinicalTrials.gov Identifier: NCT01440569|
Recruitment Status : Completed
First Posted : September 26, 2011
Results First Posted : October 28, 2014
Last Update Posted : December 14, 2016
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 adults with no darunavir (DRV) resistance-associated mutations.
After the Week 48 Visit, participants will be given the option to participate in an open-label rollover phase to receive cobicistat and attend visits every 12 weeks until it becomes commercially available, or until Gilead Sciences elects to terminate development of cobicistat.
|Condition or disease||Intervention/treatment||Phase|
|Acquired Immunodeficiency Syndrome HIV Infections||Drug: COBI Drug: DRV Drug: NRTIs||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||314 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||October 2015|
Experimental: COBI-boosted DRV
Participants will receive DRV+COBI+2 investigator-selected NRTIs for 48 weeks, and may continue their regimen in the open-label rollover phase.
150 mg tablet administered orally with food once daily
800 mg (2 x 400 mg tablets) administered orally with food once daily
Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.
- Percentage of Participants With Onset of Any Treatment-emergent Grade 3 or 4 Adverse Event Between Baseline and Week 24 [ Time Frame: Up to 24 weeks ]
- Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 24 (Snapshot Analysis) [ Time Frame: Week 24 ]
- Percentage of Participants Achieving HIV-1 RNA < 50 Copies/mL at Week 48 (Snapshot Analysis) [ Time Frame: Week 48 ]
- Change From Baseline in CD4+ Cell Count at Week 24 [ Time Frame: Baseline; Week 24 ]
- Change From Baseline in CD4+ Cell Count at Week 48 [ Time Frame: Baseline; Week 48 ]
- Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 24 [ Time Frame: Up to 24 weeks ]
- Percentage of Participants Experiencing Any Treatment-emergent Adverse Event and Any Treatment-emergent Adverse Event Leading to Discontinuation of Study Drug Through Week 48 [ Time Frame: Up to 48 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01440569
Show 49 Study Locations
|Study Director:||Marshall Fordyce, MD||Gilead Sciences|