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Sponsored by: |
Glaxo Wellcome |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002047 |
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.
Condition | Intervention |
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HIV Infections Kidney Failure, Chronic |
Drug: Zidovudine |
Study Type: | Interventional |
Study Design: | Treatment, Dose Comparison |
Official Title: | Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 weeks of study entry:
- Any other experimental therapy. Drugs which cause significant bone marrow suppression. Rifampin or rifampin derivatives. Cytolytic chemotherapy. Drugs which cause significant hepatotoxicity.
Excluded within 4 weeks of study entry:
- Immunomodulating agents, including steroids, interferon, Isoprinosine, and interleukin 2.
Excluded within 8 weeks of study entry:
- Other antiretroviral agents (e.g., zidovudine [AZT], suramin, ribavirin, HPA-23, foscarnet, dextran sulfate, disulfiram, ddA/ddC, or dideoxycytidine).
Active drug or alcohol abuse.
Study ID Numbers: | 014H, 27433-19 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002047 |
Health Authority: | United States: Food and Drug Administration |
Kidney Failure, Chronic Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Renal Dialysis |
Sexually Transmitted Diseases, Viral Renal Insufficiency Acquired Immunodeficiency Syndrome Kidney Failure, Chronic Zidovudine AIDS-Related Complex Immunologic Deficiency Syndromes Virus Diseases |
Urologic Diseases Renal Insufficiency, Chronic HIV Infections Sexually Transmitted Diseases Kidney Diseases Retroviridae Infections Kidney Failure |
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 |