Trials / Completed
CompletedNCT01440569
Safety and Efficacy of Cobicistat-boosted Darunavir in HIV Infected Adults
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | COBI | 150 mg tablet administered orally with food once daily |
| DRUG | DRV | 800 mg (2 x 400 mg tablets) administered orally with food once daily |
| DRUG | NRTIs | 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. |
Timeline
- Start date
- 2011-09-01
- Primary completion
- 2012-08-01
- Completion
- 2015-10-01
- First posted
- 2011-09-26
- Last updated
- 2016-12-14
- Results posted
- 2014-10-28
Locations
49 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01440569. Inclusion in this directory is not an endorsement.