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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 1992 by National Institute of Allergy and Infectious Diseases (NIAID).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Glaxo Wellcome
Information provided by:
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000662
First received: November 2, 1999
Last updated: August 1, 2008
Last verified: April 1992
  Purpose

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.


Condition Intervention
HIV Infections
Drug: Zidovudine

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

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.

  Eligibility

Ages Eligible for Study:   3 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000662

Locations
United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709
Sponsors and Collaborators
Glaxo Wellcome
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00000662     History of Changes
Other Study ID Numbers: TX 304, FDA 43A
Study First Received: November 2, 1999
Last Updated: August 1, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drugs, Investigational
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Zidovudine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Zidovudine
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antimetabolites
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014