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| Sponsored by: |
Glaxo Wellcome |
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002020 |
Purpose
To evaluate the safety and tolerance, in patients with severe clinical manifestations of HIV infection, of zidovudine (AZT) administered daily for 48 weeks as a low dose every 4 hours or a higher dose every 12 hours.
| Condition | Intervention |
|
HIV Infections |
Drug: Zidovudine |
| MedlinePlus related topics: | AIDS |
| Drug Information available for: | Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Dose Comparison |
| Official Title: | Trial of an Alternative Dosing Regimen of Oral Retrovir in Patients With AIDS or Advanced ARC |
Eligibility
| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Prophylaxis or treatment for Pneumocystis carinii pneumonia (PCP) consisting of either trimethoprim / sulfamethoxazole, aerosolized pentamidine, pyrimethamine / sulfadoxine, or dapsone allowed at the discretion of the investigator.
Patients with the following are excluded:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Cytolytic chemotherapy. Drugs which cause significant nephrotoxicity or hepatotoxicity.
Excluded within 4 weeks of entry:
- Immunomodulating agents, including pharmacological doses of steroids for more than 10 days (except for management of severe PCP in which case duration should not exceed 21 days). Interferon. Isoprinosine. IL-2.
Excluded within 8 weeks of entry:
-
Antiretroviral agents including:
- Ribavirin. Dideoxycytidine (ddC). Dideoxyadenosine (ddA). Didanosine (ddI). Foscarnet. Dextran Sulfate. AL-721. Retrovir (Zidovudine, AZT) for greater than 4 weeks or within 90 days of study entry, or patients who originally discontinued Retrovir due to drug-related toxicity. Drugs metabolized by hepatic glucuronidation may alter the metabolism of Retrovir and should not be used chronically.
Prior Treatment:
Excluded:
Known active drug or alcohol abuse.
Contacts and Locations| United States, Arizona | |||||
| Univ of Arizona / Health Science Ctr | |||||
| Tucson, Arizona, United States, 85724 | |||||
| United States, Illinois | |||||
| Rush Presbyterian - Saint Luke's Med Ctr | |||||
| Chicago, Illinois, United States, 60612 | |||||
| Northwestern Univ Med School | |||||
| Chicago, Illinois, United States, 60611 | |||||
| Cook County Hosp | |||||
| Chicago, Illinois, United States, 60612 | |||||
| United States, Missouri | |||||
| Univ of Missouri at Kansas City School of Medicine | |||||
| Kansas City, Missouri, United States, 64108 | |||||
| United States, New Jersey | |||||
| North Jersey Community Research Initiative | |||||
| Newark, New Jersey, United States, 071032842 | |||||
| United States, New Mexico | |||||
| Univ of New Mexico Hlth Sciences Ctr / Dept of Med | |||||
| Albuquerque, New Mexico, United States, 87131 | |||||
| United States, New York | |||||
| Northshore Hosp / Cornell Univ | |||||
| Manhasset, New York, United States, 11030 | |||||
| United States, Pennsylvania | |||||
| Univ of Pennsylvania / HIV Clinic | |||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| United States, Texas | |||||
| Univ TX Galveston Med Branch | |||||
| Galveston, Texas, United States, 77550 | |||||
| Baylor College of Medicine | |||||
| Houston, Texas, United States, 77030 | |||||
| Puerto Rico | |||||
| San Juan Veterans Administration Med Ctr | |||||
| San Juan, Puerto Rico, 009275800 | |||||
| Glaxo Wellcome |
More Information
| Study ID Numbers: | 014L, 28 |
| First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002020 |
| Health Authority: | United States: Food and Drug Administration |
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