A Phase II Efficacy Study Comparing 2',3'-Dideoxyinosine (ddI) (BMY-40900) and Zidovudine Therapy of Patients With HIV Infection Who Have Been on Long Term Zidovudine Treatment
- Conditions
- HIV Infections
- Registration Number
- NCT00000671
- Brief Summary
To compare the effectiveness and toxicity of didanosine (ddI) and zidovudine (AZT) in patients with AIDS or advanced AIDS-related complex (ARC) who have tolerated AZT therapy for 12 months or longer. Per amendment, asymptomatic patients with CD4 counts less than 200 cells/mm3 are eligible.
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 of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.
- 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 of HIV with less apparent toxicity than AZT. Studies indicate that ddI remains active in the body for at least 12 hours; thus benefits of ddI might be achieved with a low frequency of drug administration.
Two dose levels of ddI, each adjusted depending on patient's weight at study entry, are compared with a variable dosage regimen of AZT (the dose which the patient is tolerating at the time of study entry). Randomization is stratified by baseline CD4 cell count (less than 100 or 100-300) and Medical Center. This study continues for at least 12 months after the entry of the first subject. Patients randomized to AZT will receive orally. All patients randomized to AZT also receive a ddI placebo at 12 hour intervals. Patients randomized to ddI receive AZT placebo.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
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)
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Univ of Pittsburgh Med School
🇺🇸Pittsburgh, Pennsylvania, United States
Harvard (Massachusetts Gen Hosp)
🇺🇸Boston, Massachusetts, United States
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Beth Israel Deaconess Med Ctr
🇺🇸Boston, Massachusetts, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Beth Israel Deaconess - West Campus
🇺🇸Boston, Massachusetts, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Edward Hines Veterans Administration Hosp
🇺🇸Hines, Illinois, United States
SUNY - Stony Brook
🇺🇸Stony Brook, New York, 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
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Stanford at Kaiser / Kaiser Permanente Med Ctr
🇺🇸San Francisco, California, United States
Mountain States Regional Hemophilia Ctr / Univ of Colorado
🇺🇸Denver, Colorado, United States
Nebraska Regional Hemophilia Ctr
🇺🇸Omaha, Nebraska, United States
Milwaukee County Med Complex
🇺🇸Milwaukee, Wisconsin, United States
Great Lakes Hemophilia Foundation
🇺🇸Milwaukee, Wisconsin, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Palo Alto Veterans Adm Med Ctr / Stanford Univ
🇺🇸Palo Alto, California, United States
UCLA CARE Ctr
🇺🇸Los Angeles, California, United States
Stanford Univ School of Medicine
🇺🇸Stanford, California, United States
Olive View Med Ctr
🇺🇸Sylmar, California, United States
Sepulveda Veterans Adm Med Ctr / Olive View Med Ctr
🇺🇸Sylmar, California, United States
G E Morey Jr
🇺🇸Fort Lauderdale, Florida, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Northwestern Univ Med School
🇺🇸Chicago, Illinois, United States
Med Ctr of Central Massachusetts
🇺🇸Worcester, Massachusetts, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Cornell Univ Med Ctr
🇺🇸New York, 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
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Mount Sinai Hemophilia Ctr / Mount Sinai Med Ctr
🇺🇸New York, New York, United States
SUNY / State Univ of New York
🇺🇸Syracuse, New York, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
Ohio State Univ Hosp Clinic
🇺🇸Columbus, Ohio, United States
Univ of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Med College of Ohio
🇺🇸Toledo, Ohio, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Univ of Washington
🇺🇸Seattle, Washington, United States
Dr Brian Buggy
🇺🇸Milwaukee, Wisconsin, United States
San Juan Veterans Administration Med Ctr
🇵🇷San Juan, Puerto Rico
Harbor UCLA Med Ctr
🇺🇸Torrance, California, United States
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr
🇺🇸Knoxville, Tennessee, United States
Dr Stephen L Green
🇺🇸Hampton, Virginia, United States
Louisiana Comprehensive Hemophilia Care Ctr
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Montefiore Med Ctr / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Bronx Veterans Administration / Mount Sinai Hosp
🇺🇸Bronx, New York, United States
Louisiana State Univ Med Ctr / Tulane Med School
🇺🇸New Orleans, Louisiana, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
🇺🇸Bronx, 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