A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
Zidovudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 3 Months to 12 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location