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| Sponsor: | Glaxo Wellcome |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002047 |
Purpose
To evaluate the safety, tolerance, and pharmacokinetics of Retrovir (AZT) administration in HIV-infected patients in renal failure receiving maintenance hemodialysis.
| Condition | Intervention |
|---|---|
|
HIV Infections Kidney Failure, Chronic |
Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure |
Eligibility| 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.
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00002047 History of Changes |
| Other Study ID Numbers: | 014H, 27433-19 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
Kidney Failure, Chronic Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine Renal Dialysis |
|
HIV Infections Acquired Immunodeficiency Syndrome Kidney Failure, Chronic Renal Insufficiency Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Renal Insufficiency, Chronic |
Kidney Diseases Urologic Diseases Zidovudine Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |