A Phase II Double-Blind Study of Delavirdine Mesylate ( U-90152 ) in Combination With Zidovudine ( AZT ) and/or Didanosine ( ddI ) Versus AZT and ddI Combination Therapy
- Conditions
- HIV Infections
- Registration Number
- NCT00000803
- Brief Summary
To determine the safety and anti-HIV activity of delavirdine mesylate ( U-90152 ) in combination with zidovudine ( AZT ) and/or didanosine ( ddI ) versus AZT/ddI combination.
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
- Detailed Description
U-90152 has demonstrated anti-HIV activity. Since the combination of this drug with either AZT or ddI has synergistic inhibitory activity against HIV-1 in vitro, and triple therapy appears to have greater inhibitory activity against HIV-1 in vitro than dual therapy, the use of U-90152 in combination with AZT and/or ddI may improve the benefits of these drugs in persons with HIV disease.
Patients are randomized to receive U-90152/AZT/ddI, U-90152/AZT, U-90152/ddI, or AZT/ddI for 48 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 471
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 (32)
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Cornell University A2201
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
USC CRS
🇺🇸Los Angeles, California, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
🇺🇸Washington, District of Columbia, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Memorial Sloan-Kettering Cancer Ctr.
🇺🇸New York, New York, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States