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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
250
UCSD Treatment Ctr
San Diego, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
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Wilmington Hosp
Wilmington, Delaware, United States
Community Research Initiative of South Florida
Coral Gables, Florida, United States
Goodgame Med Group
Maitland, Florida, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Chandler Med Ctr
Lexington, Kentucky, United States
Kansas City AIDS Research Consortium
Kansas City, Missouri, United States
Community Research Initiative on AIDS
New York, New York, United States
Med College of Ohio
Toledo, Ohio, United States
...and 8 more locations