A Randomized, Double-Blind Phase II/III Trial of Monotherapy vs. Combination Therapy With Nucleoside Analogs in HIV-Infected Persons With CD4 Cells of 200-500/mm3
- Conditions
- HIV Infections
- Registration Number
- NCT00000625
- Brief Summary
To determine the efficacy and safety of zidovudine ( AZT ) versus didanosine ( ddI ), AZT plus ddI, and AZT plus zalcitabine ( ddC ) in preventing disease progression in HIV-infected patients with CD4 counts of 200-500 cells/mm3.
- Detailed Description
Patients are randomized to receive AZT alone, AZT and ddI, AZT and ddC, or ddI alone for at least 2 years. Patients who develop AIDS or whose CD4 count falls to 50 percent or less of baseline are crossed over to another treatment arm.
PER AMENDMENT 4/5/95: Study treatment will be available until 10/31/95 at the latest for patients still taking study medications on 4/30/95, so that follow-up trials may be completed and approved.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2100
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 (58)
USC CRS
🇺🇸Los Angeles, California, United States
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
🇺🇸Boston, Massachusetts, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Med. Ctr., ACTG CRS
🇺🇸Boston, Massachusetts, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
NYU Med. Ctr., Dept. of Medicine
🇺🇸New York, New York, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
Emory Univ. Hemophilia Program Office
🇺🇸Atlanta, Georgia, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Duke Univ. Med. Ctr. Adult CRS
🇺🇸Durham, North Carolina, United States
Wake County Health and Human Services CRS
🇺🇸Raleigh, North Carolina, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hosp., Div. of Infectious Disease
🇺🇸Boston, Massachusetts, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
Memorial Sloan-Kettering Cancer Ctr.
🇺🇸New York, New York, United States
NJ Med. School CRS
🇺🇸Newark, New Jersey, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
Cornell University A2201
🇺🇸New York, New York, United States
Howard University Hosp., Div. of Infectious Diseases, ACTU
🇺🇸Washington, District of Columbia, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
🇺🇸Oakland, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
Regional Center for Infectious Disease, Wendover Medical Center CRS
🇺🇸Greensboro, North Carolina, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Carolinas HealthCare System, Carolinas Med. Ctr.
🇺🇸Charlotte, North Carolina, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Tulane/LSU Maternal/Child CRS
🇺🇸New Orleans, Louisiana, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Tulane Hemophilia Treatment Ctr.
🇺🇸New Orleans, Louisiana, United States
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTU
🇺🇸New Orleans, Louisiana, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
MetroHealth CRS
🇺🇸Cleveland, Ohio, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Case CRS
🇺🇸Cleveland, Ohio, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States