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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000701

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

12

Expected to finish

1990-02-01

Last updated by the study team

2021-11-03

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Concurrent Treatment:
• Allowed:
• Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).

You may not qualify if…

• Co-existing Condition:
• Children with the following conditions are excluded:
• Asymptomatic with T-lymphocyte deficiency.
• Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
• Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
• Hemoglobinopathy including sickle cell anemia.
• Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.
• Children with the following conditions are excluded:
• Asymptomatic with T-lymphocyte deficiency.
• Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
• Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
• Hemoglobinopathy including sickle cell anemia.
• Congenital infections such as toxoplasmosis or herpes simplex virus infection in the first month after birth or cytomegalovirus infection in the first 6 months after birth.
• Prior Medication:
• Excluded:
• Suramin.
• Ribavirin.
• HPA 23.
• Phosphonoformate.
• Ansamycin.
• Interleukin 2.
• Interferon.
• Excluded within 30 days of study entry:
• All cytolytic chemotherapeutic agents, immunomodulating agents including steroids and immunoglobulin preparations.
• Antivirals (acyclovir, ganciclovir).

Where it is running

• Univ of Miami School of Medicine — Miami, Florida, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.