Comparison of ddI Versus Zidovudine in HIV-Infected Patients
- Conditions
- HIV Infections
- Registration Number
- NCT00000979
- Brief Summary
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS, advanced AIDS-related complex (ARC), or asymptomatic infection with CD4 counts \< 200 cells/mm3.
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.
- Detailed Description
AZT is effective in reducing mortality in patients with AIDS who receive the drug after the first episode of Pneumocystis carinii pneumonia (PCP) and in patients with advanced ARC. However, AZT therapy has been associated with significant toxicities. In addition, the effectiveness of AZT appears to decrease during the second and third years of therapy. For these reasons, the development of alternative therapy that would be at least as effective but less toxic is of great importance. The drug ddI is an antiviral agent that inhibits replication (reproduction) of HIV with less apparent toxicity than AZT.
AMENDED: 9/28/90 Patients are assigned to one of 2 treatments under a double-blind, randomly allocated, experimental design if their duration of prior AZT therapy is 0 to 16 weeks. (Patients who entered with no more than 16 weeks prior AZT and who were randomized to ddI will continue to be dosed at that level, adjusted for weight, and followed as originally planned.) Patients are assigned to one of 3 treatments as explained prior to this amendment if their duration of prior to AZT therapy is greater than 16 weeks. Original design: Patients are assigned to one of three treatments under a double-blind randomly allocated experimental design. ddI will be administered at two dose levels.
It is anticipated that patients will be seen as outpatients every 2 weeks for the first 4 weeks of the study and monthly thereafter. This study continues for at least 18 months after the entry of the first subject.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
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 (71)
Whitman - Walker Clinic
🇺🇸Washington, District of Columbia, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Med Ctr of Central Massachusetts
🇺🇸Worcester, Massachusetts, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
G E Morey Jr
🇺🇸Fort Lauderdale, Florida, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Univ TX Galveston Med Branch
🇺🇸Galveston, Texas, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Med College of Ohio
🇺🇸Toledo, Ohio, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
🇺🇸Denver, Colorado, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Nebraska Regional Hemophilia Ctr
🇺🇸Omaha, Nebraska, United States
Dr Brian Buggy
🇺🇸Milwaukee, Wisconsin, United States
Univ of Utah School of Medicine
🇺🇸Salt Lake City, Utah, United States
Milwaukee County Med Complex
🇺🇸Milwaukee, Wisconsin, United States
Great Lakes Hemophilia Foundation
🇺🇸Milwaukee, Wisconsin, United States
Olive View Med Ctr
🇺🇸Sylmar, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
🇺🇸Palo Alto, California, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
🇺🇸Sylmar, California, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Louisiana State Univ Med Ctr / Tulane Med School
🇺🇸New Orleans, Louisiana, United States
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Bowman Gray School of Medicine / Wake Forest Univ
🇺🇸Winston-Salem, North Carolina, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, New York, United States
Edward Hines Veterans Administration Hosp
🇺🇸Hines, Illinois, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Beth Israel Med Ctr / Peter Krueger Clinic
🇺🇸New York, New York, United States
Cornell Univ Med Ctr
🇺🇸New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Dr Stephen L Green
🇺🇸Hampton, Virginia, United States
SUNY - Stony Brook
🇺🇸Stony Brook, New York, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Louisiana Comprehensive Hemophilia Care Ctr
🇺🇸New Orleans, Louisiana, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States