Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
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 |
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.
Ages Eligible for Study: | 3 Months to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Treatment:
Allowed:
Criteria for children 3 months to less than 15 months of age:
OR
Patients must meet two of the following criteria:
Be immunosuppressed defined as having:
Note:
Criteria for children 15 months to 12 years of age:
OR
Patients must meet one of the following criteria:
Exclusion Criteria
Co-existing Condition:
Patients with known hypersensitivity to AZT are excluded.
Patients with the following are excluded:
Study ID Numbers: | TX 304, FDA 43A |
Study First Received: | November 2, 1999 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00000662 |
Health Authority: | United States: Federal Government |
Drugs, Investigational Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome |
Zidovudine AIDS-Related Complex Retroviridae Infections Immunologic Deficiency Syndromes |
Antimetabolites Anti-Infective Agents RNA Virus Infections Anti-HIV Agents Slow Virus Diseases Immune System Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors |
Infection Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |