Open Label Study of 908/RTV in Combination With Other PIs for the Treatment of Multi PI-Experienced HIV Subjects
Phase 3
Terminated
- Conditions
- HIV-1
- Registration Number
- NCT00144833
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
For HIV-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. This study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The average area under the curve minus baseline [AAUCMB] in plasma HIV-1 RNA at 24 Weeks when each are administered in combination with an optimised background therapy, in a multiple PI-experienced population experiencing virological failure. 24 weeks
- Secondary Outcome Measures
Name Time Method Efficacy (AAUCMB) at 48 weeks, safety, tolerability(incidence and nature of AEs and laboratory abnormalities) at week 24 and 48, CD4 change from baseline at week 24 and 48, and the steady-state plasma APV and LPV through concentrations. 48 weeks
Trial Locations
- Locations (3)
GSK Clinical Trials Call Center
🇬🇧London, United Kingdom
GSK Clinical Trials Call Centre
🇮🇹Torino, Italy
GSK Clinical Trials call Center
🇬🇧Birmingham, United Kingdom