HIV Infections Clinical Trial
Official title:
A Multicenter Phase I Trial To Evaluate the Safety and Pharmacokinetics of Intravenous and Oral Zidovudine in Infants With Perinatal Human Immunodeficiency Virus (HIV) Exposure
To determine if intravenous (IV) and oral zidovudine (AZT) can be safely given to children aged 1 day to 3 months who were born to mothers with an HIV infection. Also to determine the correct dose of AZT for young children. Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother with HIV infection or at high risk for acquisition of HIV, and the number of cases in children is expected to increase over the next several years. AZT therapy may be effective in altering the course of the disease and decreasing the high mortality in these children. It is also possible that early intervention with AZT may prevent the establishment of HIV contracted before, during, or just after birth.
Of a total of 908 pediatric AIDS cases, 78 percent have acquired HIV infection from a mother
with HIV infection or at high risk for acquisition of HIV, and the number of cases in
children is expected to increase over the next several years. AZT therapy may be effective
in altering the course of the disease and decreasing the high mortality in these children.
It is also possible that early intervention with AZT may prevent the establishment of HIV
contracted before, during, or just after birth.
The children entered in this study receive oral and IV AZT. The first 6 children receive 2
IV doses and 2 oral doses over a 2-week period, then 4 weeks of continuous oral dosing (4
doses per day). The remaining 12 children receive
1 IV dose and 1 oral dose followed by 6 weeks of oral AZT (4 doses per day) and a second IV
dose at the end of the study. Each child is under the care of a specialist in pediatrics and
has a physical examination and laboratory tests before starting AZT and 6 times while taking
AZT to make sure the drug is not having a toxic effect on the child. A single cerebrospinal
fluid (CSF) sample is taken from the last 12 children entering the study, so that the level
of the AZT reaching the brain can be measured. The child returns to the hospital or clinic 4
weeks after the end of therapy to make sure that there are no delayed toxic effects.
;
Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment
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