Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00009061
- Lead Sponsor
- Glaxo Wellcome
- Brief Summary
The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.
- Detailed Description
Patients are randomized to 1 of 2 treatment arms. One arm is treated with GW433908/RTV plus ABC and 3TC. The other is treated with NFV plus ABC and 3TC. Each group is treated for 48 weeks. The following are compared in the 2 arms: 1) magnitude and durability of antiviral response; 2) safety, tolerance, and antiviral response after 24 and 48 weeks of therapy; 3) time to treatment failure; 4) immunologic response; 5) occurrence of events related to metabolic abnormalities; and 6) development of viral resistance in a subset of patients following treatment. Also studied are: 1) steady-state plasma drug trough concentrations; 2) demographic, virologic, immunologic, pharmacologic, and adherence factors that may be associated with treatment outcome; 3) patient adherence to the drug regimens; 4) study medication utilization; and 5) resource utilization.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 624
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States
LAGLC
🇺🇸Los Angeles, California, United States
Kaiser Hospital
🇺🇸Sacramento, California, United States
Park Ctr for Health / Keith Vrhel
🇺🇸San Diego, California, United States
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Infectious Disease Consultants
🇺🇸Altamonte Springs, Florida, United States
CRI of South Florida
🇺🇸Coral Gables, Florida, United States
Therafirst Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Scroll for more (27 remaining)Orange County Ctr for Special Immunology🇺🇸Fountain Valley, California, United States