GW873140 In Combination With Combivir In HIV Infected Subjects
Phase 2
Terminated
- Conditions
- Infection, Human Immunodeficiency Virus IHIV Infection
- Registration Number
- NCT00104429
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Combivir in HIV infected, untreated subjects.
- Detailed Description
A Phase IIb, 96 week, randomized, partially double-blinded, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with Combivir (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 125
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of subjects with viral loads <400 copies/mL remaining on randomized treatment through Week 12
- Secondary Outcome Measures
Name Time Method - Comparison of safety and tolerability of different dosage regimens of GW873140 plus Combivir to standard of care regimen. - Assessment of drug resistance over time. - Co-receptor tropism following virological failure.
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧London, United Kingdom