The Safety of Different Dose Levels of Zidovudine in HIV-Infected Children
- Conditions
- HIV Infections
- Registration Number
- NCT00000983
- Brief Summary
To evaluate and compare differences in tolerance and side effects associated with two different dosages of zidovudine (AZT) when used to treat children with HIV infection. Other goals are to evaluate and compare the degree of change in neurodevelopmental disease and determine whether there are differences in the rate and degree of toxicities associated with one versus the other dosage.
AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.
- Detailed Description
AZT has been shown to decrease the death rate and frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. Thus, it is likely that symptomatic HIV infected children may also benefit from AZT. Studies of the safety and pharmacokinetics (blood levels) in children have indicated that AZT can be given to children in doses that can be tolerated and that can be assumed to be therapeutic. Those currently taking care of infected children no longer feel it is ethical to conduct an AZT/placebo (inactive substance) trial. In addition, given the information learned from studies of adult patients that shows effectiveness of AZT at lower doses, experience with an equivalent lower dose in children needs to be studied.
All participants are randomized to receive AZT at 1 of 2 doses. Patients are stratified according to whether CD4 cell counts are \> or \< 500 cells/mm3 as well as whether symptoms are mild to moderate or if patients have lymphocytic interstitial pneumonitis (LIP). Medication is dispensed every other week for the first 8 weeks and monthly until week 104, then either monthly or every 3 months. Safety and effectiveness of the treatment program are evaluated at 6-month intervals to assess whether it is appropriate to continue the study as originally designed. Patients are evaluated every 2 weeks for the first 8 weeks, monthly until week 104, every 3 months until week 208, and then every 6 months thereafter.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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 (51)
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Cedars Sinai / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Emory Univ School of Medicine
🇺🇸Atlanta, Georgia, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Univ of Illinois College of Medicine
🇺🇸Chicago, Illinois, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Boston Med Ctr
🇺🇸Boston, Massachusetts, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Univ of Connecticut Health Ctr / Pediatrics
🇺🇸Farmington, Connecticut, United States
Children's Natl Med Ctr
🇺🇸Washington, District of Columbia, United States
UPR Children's Hosp / San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
🇵🇷Bayamon, Puerto Rico
San Juan City Hosp
🇵🇷San Juan, Puerto Rico
Holmes Hosp / Univ of Cincinnati Med Ctr
🇺🇸Cincinnati, Ohio, United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
🇺🇸Brooklyn, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
🇺🇸New York, New York, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Columbia Univ Babies' Hosp
🇺🇸New York, New York, United States
Bowman Gray School of Medicine / North Carolina Baptist Hosp
🇺🇸Winston-Salem, North Carolina, United States
Hemophilia Ctr of Western PA / Univ of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Schneider Children's Hosp / Long Island Jewish Med Ctr
🇺🇸New Hyde Park, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Los Angeles County - USC Med Ctr
🇺🇸Los Angeles, California, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Jewish Hosp Ctr of Long Island / Pediatrics
🇺🇸Jamaica, New York, United States
Cornell Univ Med College
🇺🇸New York, New York, United States
Westchester Hosp / New York Med College / Pediatrics
🇺🇸Valhalla, New York, United States
Metropolitan Hosp Ctr
🇺🇸New York, New York, United States
Texas Children's Hosp / Baylor Univ
🇺🇸Houston, Texas, United States
Ctr for Special Immunology
🇺🇸Fort Lauderdale, Florida, United States
Kaiser Permanente / UCLA Med Ctr
🇺🇸Downey, California, United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
🇺🇸San Francisco, California, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Univ of Massachusetts Med Ctr
🇺🇸Worcester, Massachusetts, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States
Lincoln Hosp Ctr / Pediatrics
🇺🇸Bronx, New York, United States
Bronx Lebanon Hosp Ctr
🇺🇸Bronx, New York, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States