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

NCT00000701 | Completed Phase 1

• 4 other identifiers: ACTG 003Protocol 26,541-004Project p5310979
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

HIV Infections

Keywords

Drug Evaluation; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine

Interventions

Zidovudine DRUG

Eligibility Criteria

• Age: 3 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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:

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Univ of Miami School of Medicine

Miami, Florida, 331361013, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• Walter EB, Weinhold KJ, Wilfert CM. Enhanced p24 antigen detection in sera from human immunodeficiency virus-infected children. Pediatr Infect Dis J. 1993 Jan;12(1):94-6. doi: 10.1097/00006454-199301000-00019. No abstract available.

  PMID: 8417433 BACKGROUND

• McKinney RE Jr, Pizzo PA, Scott GB, Parks WP, Maha MA, Lehrman SN, Riggs M, Eddy J, Lane BA, Eppes SC, et al. Safety and tolerance of intermittent intravenous and oral zidovudine therapy in human immunodeficiency virus-infected pediatric patients. Pediatric Zidovudine Phase I Study Group. J Pediatr. 1990 Apr;116(4):640-7. doi: 10.1016/s0022-3476(05)81619-1.

  PMID: 2181102 BACKGROUND

• Dolin R, Graham BS, Greenberg SB, Tacket CO, Belshe RB, Midthun K, Clements ML, Gorse GJ, Horgan BW, Atmar RL, et al. 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. Ann Intern Med. 1991 Jan 15;114(2):119-27. doi: 10.7326/0003-4819-114-2-119.

  PMID: 1984386 BACKGROUND

• Mitchell C, Scott G, Hutto C, Mastrucci T, Gourley J, Owens C, Sajous M. Safety and tolerance of zidovudine in pediatric AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):200 (abstract no FB488)

  BACKGROUND

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome; AIDS-Related Complex

Interventions

Zidovudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Scott G

  STUDY CHAIR

• Wilfert C

  STUDY CHAIR

• Pizzo P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: February 1, 1990
• Last Updated: November 3, 2021

Record last verified: 2021-10

Locations

US (2)