A Phase 2B Multicenter, Randomized, Comparative Trial Of UK-453,061 Versus Etravirine In Combination With Darunavir/Ritonavir And A Nucleos(t)ide Reverse Transcriptase Inhibitor For The Treatment Of Antiretroviral Experienced HIV-1 Infected Subjects With Evidence Of NNRTI Resistant HIV-1
Phase 2
- Conditions
- Health Condition 1: null- HIV-1
- Registration Number
- CTRI/2010/091/001049
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Applicable
- Sex
- Not specified
- Target Recruitment
- 90
Inclusion Criteria
1.Male or female at least 18 years of age available for a follow-up period of at least 96 weeks.
2.HIV 1 RNA viral load of greater then 500 copies/mL.
3.Negative urine pregnancy test.
Exclusion Criteria
1. Suspected or documented active, untreated HIV-1 related opportunistic infection or other condition requiring acute therapy at the time of randomization.
2. Subjects with acute Hepatitis B and/or C within 30 days of randomization.
3. Previous use of Darunavir or etravirine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method