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...
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A Phase I Evaluation of Azidothymidine (AZT) in Children with Acquired Immune Deficiency Syndrome (AIDS) or AIDS Related Complex (ARC)
Medical trial
ClinicalTrials.gov Identifier:
- NCT00000701
Type of trial:
Phase:
Expected total enrollment:
- 12
Minimum age for eligibility:
- 1
Maximum age for eligibility:
- 12
Eligibility inclusion criteria:
- * Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).
- Nutritional support not exceeding 120 calories/kg/day (hyperalimentation or dietary supplements including vitamin, folate, iron supplements).
Eligibility exclusion criteria:
- 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.
- Hemoglobinopathy including sickle cell anemia.
- Clinical evidence of active infection of acute nature or active significant or clinically apparent opportunistic infection at time of entry into study.
- # Asymptomatic with T-lymphocyte deficiency.
- Asymptomatic viremic patients or those not meeting definition criteria of AIDS related complex (ARC) or AIDS.
Location:
View entire collection »Health authority:
References:
- Safety and tolerance of zidovudine in pediatric AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):200 (abstract no FB488)
- Enhanced p24 antigen detection in sera from human immunodeficiency virus-infected children
- Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group.
- The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network.
Diseases:
Treatment being tested:
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