The Safety and Effectiveness of Nevirapine and Zidovudine, Given Separately and Together, in HIV-1 Infected Patients Who Have No Symptoms of the Disease
- Conditions
- HIV Infections
- Registration Number
- NCT00002324
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
PRIMARY: To compare the effect of nevirapine versus placebo alone or in combination with zidovudine (AZT) on CD4 T-cell count and percentage after 3 and 6 months of treatment. To evaluate the safety and tolerance of nevirapine alone or in combination with AZT.
SECONDARY: To compare the effects of the various treatment combinations on virologic and immunologic markers.
- Detailed Description
In Part I, patients who have had prior AZT therapy receive either nevirapine or placebo in combination with AZT. In Part II, patients who are nucleoside naive receive either nevirapine or matching placebo. After 6 months, patients receive open-label nevirapine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
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 (18)
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Saint Francis Mem Hosp
🇺🇸San Francisco, California, United States
Univ of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Nelson-Tebedo Community Clinic
🇺🇸Dallas, Texas, United States
Houston Clinical Research Network
🇺🇸Houston, Texas, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Associates Med and Mental Health
🇺🇸Tulsa, Oklahoma, United States
Goodgame Med Group
🇺🇸Maitland, Florida, United States
Kansas City AIDS Research Consortium
🇺🇸Kansas City, Missouri, United States
Wilmington Hosp
🇺🇸Wilmington, Delaware, United States
Chandler Med Ctr
🇺🇸Lexington, Kentucky, United States
Community Research Initiative on AIDS
🇺🇸New York, New York, United States
Med College of Ohio
🇺🇸Toledo, Ohio, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Dr Alfred F Burnside Jr
🇺🇸Columbia, South Carolina, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Community Research Initiative of South Florida
🇺🇸Coral Gables, Florida, United States