drugset / Trial / NCT01440569
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2011-09
- Primary completion
- 2012-08
- Completion
- 2015-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abacavir | Other / unclassified | — | — |
| Subject | COBI | Unknown | 150 mg | Oral |
| Subject | DRV | Unknown | 800 mg | Oral |
| Subject | Didanosine | Small molecule | — | — |
| Subject | Lamivudine | Other / unclassified | — | — |
| Subject | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Subject | Zidovudine | Small molecule | — | — |
| Subject | emtricitabine | Other / unclassified | — | — |