GW640385 Plus Ritonavir And NRTIs For 48 Weeks In HIV-1 Infected Adults
Phase 2
Completed
- Conditions
- Infection, Human Immunodeficiency Virus IHIV Infection
- Registration Number
- NCT00257621
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
This is a proof of concept (POC) single arm study of GW640385, a protease inhibitor, in combination with RTV and 2 or more nucleoside reverse transcriptase inhibitors (NRTI) backbone. This study has a 48 week duration and is open to both treatment naive and experienced patients who are HIV positive. There are 3 intensive pharmacokinetic (PK) visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of subjects with plasma HIV-1 RNA <400 copies/ml. Incidence of serious adverse events, rash and thyroid function abnormalities. GW640385 PK parameters. throughout the study
- Secondary Outcome Measures
Name Time Method Changes over time in HIV-1 viral load and CD4+ cell counts. Incidence of adverse events and laboratory abnormalities. GW640385 and RTV PK parameters. Development of resistance in subjects with virologic failure. throughout the study
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Seattle, Washington, United States