To assess the safety and toxicity of zidovudine (AZT)/didanosine (ddI) versus AZT/ddI combined with nevirapine in HIV-infected patients, and to obtain preliminary anti-HIV activity data using immunologic and virologic markers. Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective.
Previous in vitro studies suggest that HIV that has already developed resistance to AZT and ddI is less able to develop resistance to nevirapine, a non-nucleoside reverse transcriptase inhibitor. Thus, convergent combination therapy with these three drugs in HIV-infected patients may prove more effective. Patients are randomized to receive AZT/ddI plus either nevirapine or placebo daily for 48 weeks, with possible extension for at least 12 weeks. At eight participating sites, ACTG 808 and 809 will be conducted as virologic and pharmacokinetic substudies.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Univ of Alabama at Birmingham
Birmingham, Alabama, United States
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States
Summitt Med Ctr / San Francisco Gen Hosp
Oakland, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
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San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
...and 34 more locations