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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002020 |
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 |
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HIV Infections |
Drug: 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 |
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:
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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.
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 |
Study ID Numbers: | 014L, 28 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002020 |
Health Authority: | United States: Food and Drug Administration |
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 |