The Safety and Effectiveness of Nevirapine Plus Lamivudine Plus Other Anti-HIV Drugs
- Conditions
- HIV Infections
- Registration Number
- NCT00002368
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To evaluate the tolerance, safety, and effectiveness of Viramune in preventing clinical AIDS progression events or death when used in combination with Lamivudine and background nucleoside therapy.
- Detailed Description
Eligible patients will be randomized to treatment with either 1) open-label 3TC twice daily plus Viramune once daily for 2 weeks and then with Viramune twice daily; or 2) open label 3TC twice daily plus Viramune placebo once daily for 2 weeks and then twice daily Viramune. Patients will start Viramune and 3TC on study day 0. Patients will be evaluated for development of AIDS progression events at months 1, 2, 3, and 4, and every 2 months thereafter until 18 months after the last patient is enrolled or 24 months, whichever occurs first.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (52)
Dr G Michael Wool
🇺🇸Los Angeles, California, United States
Northwestern Univ / Division of Infectious Diseases
🇺🇸Chicago, Illinois, United States
Rush Presbyterian / Saint Luke's Med Ctr / Infect Dis
🇺🇸Chicago, Illinois, United States
Advanced Research Management
🇺🇸Seattle, Washington, United States
AIDS Research Ctr / Palo Alto VA Health Care System
🇺🇸Palo Alto, California, United States
Anthony LaMarca
🇺🇸Fort Lauderdale, Florida, United States
Drug Research and Analysis Corp
🇺🇸Montgomery, Alabama, United States
Wilmington Hosp
🇺🇸Wilmington, Delaware, United States
AIDS Community Research Consortium
🇺🇸Redwood City, California, United States
UCLA School of Medicine / Ctr for Research and Education
🇺🇸Los Angeles, California, United States
Omega Med Research
🇺🇸Providence, Rhode Island, United States
Infectious Disease Specialists
🇺🇸Colorado Springs, Colorado, United States
Univ of Texas Med Branch / Div of Infectious Dis
🇺🇸Galveston, Texas, United States
Novum Inc
🇺🇸Pittsburgh, Pennsylvania, United States
Dr David Kaufman
🇺🇸New York, New York, United States
Harbor - UCLA Med Ctr
🇺🇸Torrance, California, United States
Dr John Pottage
🇺🇸Chicago, Illinois, United States
Beth Israel Hosp / Virology Research Clinic
🇺🇸Boston, Massachusetts, United States
Goodgame Med Group
🇺🇸Maitland, Florida, United States
Dr Daniel H Gervich
🇺🇸Des Moines, Iowa, United States
Palm Beach Research Ctr
🇺🇸West Palm Beach, Florida, United States
Univ of Iowa
🇺🇸Iowa City, Iowa, United States
New England Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Kentucky Med Cntr / Dept of Med / Div of ID
🇺🇸Lexington, Kentucky, United States
P Andrew Coley
🇺🇸Jacksonville, Florida, United States
North Broward Hosp District
🇺🇸Fort Lauderdale, Florida, United States
Saint Vincent Med Ctr
🇺🇸Staten Island, New York, United States
Med Research Ctr
🇺🇸New Orleans, Louisiana, United States
Nelson Tebedo Health Resource Ctr
🇺🇸Dallas, Texas, United States
Walter Gaman
🇺🇸Irving, Texas, United States
Indiana Univ Med School
🇺🇸Indianapolis, Indiana, United States
Houston Clinical Research Network / Div of Montrose Clinic
🇺🇸Houston, Texas, United States
ViRx Inc
🇺🇸San Francisco, California, United States
San Francisco Gen Hosp / UCSF AIDS Program
🇺🇸San Francisco, California, United States
International Medicine and Infectious Disease
🇺🇸Minneapolis, Minnesota, United States
Denver Public Health
🇺🇸Denver, Colorado, United States
Dr Miguel Mogyoros / Clinical Research Dept
🇺🇸Denver, Colorado, United States
Infectious Disease Research Institute Inc
🇺🇸Tampa, Florida, United States
The Research and Education Group
🇺🇸Portland, Oregon, United States
Hershey Med Ctr / Dept of Med / Div of Hematology
🇺🇸Hershey, Pennsylvania, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Hampton Roads Med Specialists
🇺🇸Hampton, Virginia, United States
Dr Robert Schwartz
🇺🇸Fort Myers, Florida, United States
Trinity Lutheran Hosp / HIV Program
🇺🇸Kansas City, Missouri, United States
McGregor Clinic / Lee County Public Health Unit
🇺🇸Fort Myers, Florida, United States
Univ of Pennsylvania / Division of Infectious Diseases
🇺🇸Philadelphia, Pennsylvania, United States
Associates in Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
New England Deaconess Hosp
🇺🇸Boston, Massachusetts, United States
Infectious Disease Associates of Central New Jersey
🇺🇸Somerville, New Jersey, United States
Med Univ of South Carolina / Div of Infect Dis
🇺🇸Charleston, South Carolina, United States
Dr Susie Sargent
🇺🇸Memphis, Tennessee, United States
Dr Alfred Burnside
🇺🇸Columbia, South Carolina, United States