The Safety and Effectiveness of Zidovudine in the Treatment of HIV-Infected Children With Mild to Moderate Symptoms
- Conditions
- HIV Infections
- Registration Number
- NCT00000990
- Brief Summary
To determine the safety and usefulness of zidovudine (AZT) for the treatment of children 3 months to 12 years of age. This study is designed to determine if children who are infected with HIV and who have a special type of lung disease called lymphocytic interstitial pneumonitis (LIP) or other early symptoms of HIV infection may derive benefit from treatment with AZT. It is hoped that this drug will prevent children from developing additional symptoms and infections and will help resolve already existing symptoms.
AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.
- Detailed Description
AZT has been shown in the laboratory to inhibit the infection of cells by HIV. AZT has been shown to decrease the mortality and the frequency of opportunistic infections in certain adult patients with symptomatic HIV infection. It is, therefore, likely that symptomatic HIV-infected children may also benefit from specific antiviral therapy.
Children who participate in the study are evaluated at a hospital outpatient clinic and are under the care of a specialist in pediatrics. Of the children who participate in the study, half receive AZT syrup and half receive a placebo (sugar solution). The investigator does not know which medication each child receives as this is decided by a random process. The children take the medication in a strawberry-flavored clear syrup every 6 hours (4 times a day), for a period of 2 years or 104 weeks. The children are monitored on an outpatient basis while receiving therapy and the tests performed on admission to the study are repeated several times during treatment. Blood samples are obtained once a week for the first 4 weeks, every other week for the next 4 weeks, and then monthly until the end of the study. At certain sites, Cerebrospinal fluid (CSF) is collected by lumbar puncture every 52 weeks to evaluate infection involving the brain and nervous system. An independent committee reviews the data collected on the children every 6 months. The drug is stopped or the dose reduced if unacceptable side effects develop. AMENDED: As of August 7, 1989 the study blind was broken, the placebo arm discontinued and the study closed to accrual as of September 25, 1989. The 6 children enrolled in the study have been offered AZT.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
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 (32)
Milton S Hershey Med Ctr
🇺🇸Hershey, Pennsylvania, United States
City Hosp Ctr at Elmhurst / Mount Sinai Hosp
🇺🇸Elmhurst, New York, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
Jack Weiler Hosp / Bronx Municipal Hosp
🇺🇸Bronx, New York, United States
Stanford Univ School of Medicine
🇺🇸Menlo Park, California, United States
Beth Israel Med Ctr / Pediatrics
🇺🇸New York, New York, United States
Columbia Univ Babies' Hosp
🇺🇸New York, New York, United States
Children's Hosp of Los Angeles/UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Martin Luther King Jr Gen Hosp / UCLA Med Ctr
🇺🇸Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
🇺🇸Los Angeles, California, United States
Cook County Hosp
🇺🇸Chicago, Illinois, United States
Johns Hopkins Hosp - Pediatric
🇺🇸Baltimore, Maryland, United States
Columbus Children's Hosp
🇺🇸Columbus, Ohio, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
UCSD Treatment Ctr
🇺🇸San Diego, California, United States
Northern California Pediatric AIDS Treatment Ctr / UCSF
🇺🇸San Francisco, California, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke Univ Med Ctr
🇺🇸Durham, North Carolina, United States
Long Beach Memorial (Pediatric)
🇺🇸Long Beach, California, United States
Kaiser Permanente / UCLA Med Ctr
🇺🇸Downey, California, United States
UCLA Med Ctr / Pediatric
🇺🇸Los Angeles, California, United States
Univ of Maryland at Baltimore / Univ Med Ctr
🇺🇸Baltimore, Maryland, United States
Children's Hosp of Boston
🇺🇸Boston, Massachusetts, United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
🇺🇸Newark, New Jersey, United States
Chicago Children's Memorial Hosp
🇺🇸Chicago, Illinois, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Harlem Hosp Ctr
🇺🇸New York, New York, United States
Hermann Hosp / Univ Texas Health Science Ctr
🇺🇸Houston, Texas, United States
Children's Hosp of Oakland
🇺🇸Oakland, California, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States