Phase 3b Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
This study is currently recruiting participants.
Verified October 2011 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01440569
First received: September 22, 2011
Last updated: October 12, 2011
Last verified: October 2011
Tracking Information | |||||
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First Received Date ICMJE | September 22, 2011 | ||||
Last Updated Date | October 12, 2011 | ||||
Start Date ICMJE | September 2011 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary safety endpoint is the onset of any treatment emergent Grade 3 or Grade 4 adverse events [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ] Onset of any treatment emergent Grade 3 or Grade 4 adverse event through 24 weeks. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01440569 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 3b Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults | ||||
Official Title ICMJE | 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 | ||||
Brief Summary | 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. |
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Detailed Description | 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 |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arm (s) | 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
Interventions:
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE | 300 | ||||
Estimated Completion Date | May 2013 | ||||
Estimated Primary Completion Date | March 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, France, Germany, Puerto Rico | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01440569 | ||||
Other Study ID Numbers ICMJE | GS-US-216-0130, 2011-003501-22 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Gilead Sciences | ||||
Study Sponsor ICMJE | Gilead Sciences | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Gilead Sciences | ||||
Verification Date | October 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |