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A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

HIV Infections Clinical Trial

Official title:
A Phase I Evaluation of Azidothymidine (AZT) in Children With Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)

Clinical Trial Summary

The study is designed to test the drug zidovudine (AZT) in children, including study of drug levels in various parts of the body fluids, safety of the drug, and its effect on different parts of the body. The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children.

Clinical Trial Description

The effects of any drug, the way a drug enters the bloodstream, the way it is used by the body, and the way the body eliminates the drug may be very different in children compared with adults. The largest group of children who have AIDS are those who are less than 2 years of age. AIDS is often first identified in infants who are about 6 months old. Studies of AZT show that it might be useful in the treatment of AIDS. Thus it is important to study the effects of the drug in children. Patients are hospitalized for 8 weeks to receive AZT through the intravenous (IV) route at 1 of 2 doses. Patients are then discharged from hospital and take AZT by mouth for 4 more weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00000701
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Completed
Phase Phase 1
Completion date February 1990
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