Search / Trial NCT00000662

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of December 03, 2023

Completed

Keywords

Drugs, Investigational Acquired Immunodeficiency Syndrome Aids Related Complex Zidovudine

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.

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00000662_2023-12-03.pdf

4.5 MB

NCT00000662_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Research Triangle Park, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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