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)
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
USC CRS
🇺🇸Los Angeles, California, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, 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
UCSD Maternal, Child, and Adolescent HIV CRS
🇺🇸San Diego, California, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
Santa Clara Valley Med. Ctr.
🇺🇸San Jose, California, United States
San Mateo County AIDS Program
🇺🇸San Mateo, California, United States
Scroll for more (48 remaining)Alabama Therapeutics CRS🇺🇸Birmingham, Alabama, United States