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

Sponsors and Collaborators:	National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome
Information provided by:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00000662

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Zidovudine

U.S. FDA Resources

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

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

National Institute of Allergy and Infectious Diseases (NIAID)

Glaxo Wellcome

More Information

Additional Information:

Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site

No publications provided

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

Study placed in the following topic categories:

Antimetabolites
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Acquired Immunodeficiency Syndrome
Zidovudine
AIDS-Related Complex
Antiviral Agents

Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Sexually Transmitted Diseases
Retroviridae Infections

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Anti-HIV Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Acquired Immunodeficiency Syndrome
Zidovudine
Enzyme Inhibitors
Infection

Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Reverse Transcriptase Inhibitors
Virus Diseases
Anti-Retroviral Agents
HIV Infections
Therapeutic Uses
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 02, 2009