A Comparison of Three Treatments for Advanced HIV Disease in Patients Who Have Received Nucleoside Therapy in the Past
- Conditions
- HIV Infections
- Registration Number
- NCT00001029
- Brief Summary
To compare the efficacy, safety and tolerance, and other clinical and immunologic effects of zidovudine (AZT) plus zalcitabine (dideoxycytidine; ddC), AZT plus didanosine (ddI), and AZT alternating monthly with ddI as measured by differences in survival among HIV-infected persons who have received 6 or more months of nucleoside monotherapy and have a CD4 count greater than or equal to 50 cells/mm3.
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
- Detailed Description
Combining two nucleoside drugs has the theoretical advantage of optimal protection against the evolution of resistant strains of HIV. However, one major problem with combination nucleoside therapy in patients with advanced disease is the increased toxicity resulting from such therapy. One approach to minimize toxicity while perhaps retaining some of the benefits of combination therapy is to alternate the two drugs.
Patients are randomized to one of three treatment arms: AZT plus ddI, AZT plus ddC, and AZT alone alternating monthly with ddI. Half of the patients receiving AZT alternating monthly with ddI will start with AZT, while the other half will start with ddI. Treatment continues until death or termination of the study. Patients are followed every 4 weeks. The study will include a subset of patients for whom virologic, pharmacokinetic, and macroneurologic assessments will be made.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 654
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 (37)
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Univ. of Nebraska Med. Ctr., Durham Outpatient Ctr.
🇺🇸Omaha, Nebraska, United States
Massachusetts General Hospital ACTG CRS
🇺🇸Boston, Massachusetts, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
Puerto Rico-AIDS CRS
🇵🇷San Juan, Puerto Rico
Univ. of Miami AIDS CRS
🇺🇸Miami, Florida, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
Stanford CRS
🇺🇸Palo Alto, California, United States
USC CRS
🇺🇸Los Angeles, 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
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Univ. of Iowa Healthcare, Div. of Infectious Diseases
🇺🇸Iowa City, Iowa, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, 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
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Memorial Sloan-Kettering Cancer Ctr.
🇺🇸New York, New York, 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
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States