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A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease Clinical research trials and A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease clinical trial. Subjects typically recieve the finest healthcare available for their A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease  A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/12 Years
Genders: Both
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, 27709
United States
Additional Information:
Study ID Numbers: TX 304; FDA 43A
Study Start Date:
Record last reviewed: April 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000662
Other Hiv Infections Studies:
1. Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen
2. Rifabutin Therapy for the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in HIV Positive Patients with CD4 Counts = or < 200: Treatment IND Study
3. Treatment of Hepatitis C in Hemophilic Patients with HIV
4. Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Maintenance Treatment for the Prevention of Relapse of Cryptococcal Meningitis in Patients With Acquired Immunodeficiency Syndrome
5. The Safety and Effectiveness of Adefovir Dipivoxil in HIV-Infected Children
Related Studies:
Other HIV Infections Clinical Trials
Other North Carolina Clinical Trials
Other Research Triangle Park Clinical Trials
A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease
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