A Randomized Comparative Trial of Zidovudine (AZT) Versus 2',3'-Dideoxyinosine (ddI) Versus AZT Plus ddI in Symptomatic HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000637
- Brief Summary
To compare the effectiveness of treatment with zidovudine (AZT) compared to didanosine (ddI) and compared to the combination of AZT and ddI as determined by survival and disease progression. To compare the relative safety and tolerance of AZT versus ddI versus AZT plus ddI in symptomatic HIV infected children; to compare the virological and immunological parameters in the three treatment groups. AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
- Detailed Description
AZT has been shown to delay the progression of AIDS in HIV infected individuals. However, bone marrow toxicity is a frequent adverse effect. Also, HIV resistance to AZT sometimes occurs in patients who initially respond to treatment, but later have progression of the disease. Thus, new drug treatments are needed. Studies of ddI in adults and children indicate some effectiveness of the drug. A direct comparison of AZT and ddI treatment in children has not been made. Combination antiviral treatment (AZT plus ddI) may give added therapeutic benefit to children.
Patients are placed by random selection into one of three groups to receive either AZT alone, ddI alone, or AZT and ddI. This is a double-blind study: neither patient nor treating physician knows which group patient is in. If patients are receiving either AZT or ddI alone and they develop drug toxicity (after dose reduction), or if HIV disease progresses, the alternative single drug is offered. If patients receiving both drugs develop drug toxicity (despite dose reduction) or if HIV disease progresses, they discontinue study drug and are offered the best alternative therapy. PER AMENDMENT 6/26/95: Initial monotherapy AZT arm is unblinded and no further crossover therapy for any arm is permitted. Patients who reach crossover criteria on initial blinded ddI or AZT+ddI will be unblinded and permanently discontinued from study drugs.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 819
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 (80)
Children's Med Ctr of Dallas
🇺🇸Dallas, Texas, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Emory Univ Hosp / Pediatrics
🇺🇸Atlanta, Georgia, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Boston City Hosp / Pediatrics
🇺🇸Boston, Massachusetts, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Children's Hosp of Seattle
🇺🇸Seattle, Washington, United States
Cincinnati Children's Hosp / Univ Hosp
🇺🇸Cincinnati, Ohio, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
🇺🇸La Jolla, California, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Kaiser Permanente / UCLA Med Ctr
🇺🇸Downey, California, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Univ of Chicago Children's Hosp
🇺🇸Chicago, Illinois, United States
Baystate Med Ctr of Springfield
🇺🇸Springfield, Massachusetts, United States
Univ of Miami (Pediatric)
🇺🇸Miami, Florida, United States
Howard Univ Hosp
🇺🇸Washington, District of Columbia, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
King's County Hosp Ctr / Pediatrics
🇺🇸Brooklyn, New York, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Mount Sinai Med Ctr / Pediatrics
🇺🇸New York, New York, United States
State Univ of New York at Stony Brook
🇺🇸Stony Brook, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Case Western Reserve Univ
🇺🇸Cleveland, Ohio, United States
Saint Jude Children's Research Hosp of Memphis
🇺🇸Memphis, Tennessee, United States
Children's Hosp of Denver
🇺🇸Denver, Colorado, United States
Children's Hosp of Michigan
🇺🇸Detroit, Michigan, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
🇺🇸Birmingham, Alabama, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
UCSF / Moffitt Hosp - Pediatric
🇺🇸San Francisco, California, United States
Univ of Connecticut Health Ctr
🇺🇸Farmington, Connecticut, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
St Louis Univ School of Medicine
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson Med School / Hershey Med Ctr
🇺🇸New Brunswick, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
🇺🇸New Brunswick, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Bronx Lebanon Hosp Ctr / Pediatrics
🇺🇸Bronx, New York, United States
Children's Hosp at Albany Med Ctr
🇺🇸Albany, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
🇺🇸Buffalo, New York, United States
SUNY - Brooklyn
🇺🇸Brooklyn, New York, United States
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Schneider Children's Hosp
🇺🇸New Hyde Park, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
🇺🇸New York, New York, United States
Westchester Hosp
🇺🇸Valhalla, New York, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Children's Hosp of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
🇺🇸Philadelphia, Pennsylvania, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
🇵🇷San Juan, Puerto Rico
UPR Children's Hosp / UPR School of Medicine
🇵🇷San Juan, Puerto Rico
Huntington Memorial Hosp / Children's Hosp of Los Angeles
🇺🇸Pasadena, California, United States
Stanford Univ School of Medicine / Pediatrics
🇺🇸Stanford, California, United States
Lincoln Hosp Ctr
🇺🇸Bronx, New York, United States
Georgetown Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Children's Hosp of Washington DC
🇺🇸Washington, District of Columbia, United States
Univ of Illinois College of Medicine / Pediatrics
🇺🇸Chicago, Illinois, United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
🇺🇸Brooklyn, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
🇺🇸Syracuse, New York, United States
North Shore Univ Hosp
🇺🇸Great Neck, New York, United States
Rhode Island Hosp / Brown Univ
🇺🇸Providence, Rhode Island, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
Yale Univ Med School
🇺🇸New Haven, Connecticut, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Med Univ of South Carolina
🇺🇸Charleston, South Carolina, United States