- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002047
Retrovir Capsules in the Treatment of HIV-Infected Patients in Renal Failure
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21201
- Univ of Maryland at Baltimore
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Patients must have:
- A positive HIV antibody test (ELISA confirmed by Western blot).
- Chronic renal failure managed by a stable hemodialysis regimen.
- Acceptable hepatic function defined by specified lab values.
- Life expectancy > 6 months.
- Enrollment is limited to 9 chronic hemodialysis patients and 9 Continuous Ambulatory Peritoneal Dialysis (CAPD) patients. These patients must be stable in their ESRD treatment regimen before entry.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Active, serious opportunistic infections at the time of study entry.
- Fever > 100 degrees F at study entry.
- Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
Patients with the following are excluded:
- Active, serious opportunistic infections at the time of study entry.
- Fever > 100 degrees F at study entry.
- Severe malabsorption (evidenced by persistent diarrhea of greater than 4 weeks duration with = or > 6 loose stools per day accompanied by significant weight loss).
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Renal Insufficiency, Chronic
- Kidney Failure, Chronic
- Renal Insufficiency
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Zidovudine
Other Study ID Numbers
- 014H
- 27433-19
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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