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)
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Nicholas Bellos
🇺🇸Dallas, Texas, United States
Therafirst Med Ctr
🇺🇸Fort Lauderdale, Florida, United States
Infectious Diseases Associates
🇺🇸Sarasota, Florida, United States
Burnside Clinic
🇺🇸Columbia, South Carolina, United States
Hahnemann Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
Brigham and Women's Hosp
🇺🇸Boston, Massachusetts, United States
Joseph C Gathe
🇺🇸Houston, Texas, United States
Specialty Med Care Ctrs of South Florida Inc
🇺🇸Miami, Florida, United States
Park Ctr for Health / Keith Vrhel
🇺🇸San Diego, California, United States
Univ of Miami Dept of Medicine
🇺🇸Miami, Florida, United States
Univ of Cincinnati / Holmes Hosp
🇺🇸Cincinnati, Ohio, United States
Infectious Disease Research Inst
🇺🇸Tampa, Florida, United States
Dupont Circle Physicians Group
🇺🇸Washington, District of Columbia, United States
Kaiser Hospital
🇺🇸Sacramento, California, United States
LAGLC
🇺🇸Los Angeles, California, United States
AIDS Research Alliance
🇺🇸West Hollywood, California, United States
Infectious Disease Consultants
🇺🇸Altamonte Springs, Florida, United States
CRI of South Florida
🇺🇸Coral Gables, Florida, United States
Jeffrey Levenson
🇺🇸St. Petersburg, Florida, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
Med College of Georgia
🇺🇸Augusta, Georgia, United States
Southampton Healthcare Inc
🇺🇸St. Louis, Missouri, United States
Indiana Univ Med School
🇺🇸Indianapolis, Indiana, United States
Abbott-Northwestern Hosp / Clinic 42
🇺🇸Minneapolis, Minnesota, United States
Hawthorne Med Associates / PAACA
🇺🇸New Bedford, Massachusetts, United States
North Shore Univ Hosp
🇺🇸Manhasset, New York, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
St Lukes - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Methodist Healthcare
🇺🇸Memphis, Tennessee, United States
VAMC New Jersey Healthcare System
🇺🇸East Orange, New Jersey, United States
Bronx Veterans Affairs Med Ctr
🇺🇸Bronx, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Orange County Ctr for Special Immunology
🇺🇸Fountain Valley, California, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States
SMO USA
🇺🇸Conyers, Georgia, United States
AIDS Healthcare Foundation
🇺🇸Los Angeles, California, United States