A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

NCT00000662 | Completed

• 2 other identifiers: TX 304FDA 43A
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To facilitate the use of zidovudine (AZT) in children who are 3 months to 12 years of age who are HIV-infected and either symptomatic or have a CD4 cell count \< 400 cells/mm3 and to monitor adverse effects of AZT. Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.

Conditions

HIV Infections

Keywords

Drugs, Investigational; 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:
• Blood transfusions for hematologic toxicity.
• Criteria for children 3 months to less than 15 months of age:
• Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).
• If antibody-negative, patient must have two positive p24 antigen determinations performed at least one week apart or have had a positive HIV culture.
• Patients must meet two of the following criteria:
• Be HIV culture positive or p24 antigen positive.
• Have at least one of the Class P-2 symptoms (by CDC criteria).
• Be immunosuppressed defined as having:
• CD4+(T4) lymphocytes = or \< 400 cells/mm3.
• Abnormal age adjusted immunoglobulin levels (IgG or IgA). Decreased helper/suppressor ratio \< 1.0.
• Note:
• In general, abnormal values for any of the above lab tests should be confirmed in 2 measurements at least 1 week apart, and other clinical causes for these abnormalities should be ruled out.
• Criteria for children 15 months to 12 years of age:

You may not qualify if:

• Co-existing Condition:
• Patients with known hypersensitivity to AZT are excluded.
• Patients with the following are excluded:
• Inability to obtain signed informed consent from a parent or legal guardian.
• Enrollment in another treatment protocol that expressly prohibits concomitant treatment with zidovudine (AZT).
• Enrollment in another clinical trial in which AZT is a treatment.
• Known hypersensitivity to AZT.

Sponsors & Collaborators

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

Study Sites (1)

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 27709, United States

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Primary Completion: May 1, 1993
• Study Completion: May 1, 1993
• Last Updated: October 31, 2016

Record last verified: 1992-04

Locations

US (1)