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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Drug: Zidovudine

Detailed Description

Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT.

This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician. The physician is responsible for obtaining informed consent, assuring that the patient meets the eligibility criteria, dispensing the medication to the patient, monitoring the patient's condition on treatment, and reporting required data to the project coordinating center.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27709
      • Glaxo Wellcome Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

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).

OR

• 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:

• Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot).

OR

• 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 one of the following criteria:

• 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, based on two measurements at least 1 week apart.

Exclusion Criteria

Co-existing Condition:

Patients with known hypersensitivity to AZT are excluded.

Patients with the following are excluded:

• Failure to meet inclusion criteria.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborators: Glaxo Wellcome

Study record dates

Study Major Dates

• Primary Completion (Actual): May 1, 1993
• Study Completion (Actual): May 1, 1993

Study Registration Dates

• First Submitted: November 2, 1999
• First Submitted That Met QC Criteria: August 30, 2001
• First Posted (Estimate): August 31, 2001

Study Record Updates

• Last Update Posted (Estimate): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: April 1, 1992

More Information

Terms related to this study

• Keywords: Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine; Drugs, Investigational
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Antimetabolites; Zidovudine
• Other Study ID Numbers: TX 304; FDA 43A