A Comparative Study of a Combination of Zidovudine, Didanosine, and Double-Blinded Nevirapine Versus a Combination of Zidovudine and Didanosine
- Conditions
- HIV Infections
- Registration Number
- NCT00000770
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 (44)
Saint Clare's Hosp and Health Ctr
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Summitt Med Ctr / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Thomas Jefferson Univ Hosp
🇺🇸Philadelphia, Pennsylvania, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Carolinas Med Ctr
🇺🇸Charlotte, North Carolina, United States
Moses H Cone Memorial Hosp
🇺🇸Greensboro, North Carolina, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
Hennepin County Med Clinic
🇺🇸Minneapolis, Minnesota, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Wake County Dept of Health
🇺🇸Raleigh, North Carolina, United States
Girard Med Ctr
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Iowa Hosp and Clinic
🇺🇸Iowa City, Iowa, United States
St Paul Ramsey Med Ctr
🇺🇸Saint Paul, Minnesota, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Nebraska Med Ctr
🇺🇸Omaha, Nebraska, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Comprehensive Health Care Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Family Health Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Samaritan Village Inc / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
North Central Bronx Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States