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NCT00001001 · ClinicalTrials.gov registry record · NA
A Study of Zidovudine in HIV-Infected Patients With Liver Disease
A NA study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT00001001 is a NA study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 39 participants.
The verdict
NCT00001001, a NA study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study Summary
To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given to patients with HIV infection and chronic liver disease. The specific aim of the study is to provide data permitting the development of guidelines for use of AZT in patients with mild, moderate, or severe liver disease. AZT is the only antiviral agent that has been shown to be effective in patients with severe HIV infection. However, AZT is largely eliminated from the body through a biochemical reaction that takes place in the liver, and it is possible that patients with underlying liver disease may have altered AZT pharmacokinetics and may metabolize AZT differently, with the result that they are susceptible to an increased risk of serious drug toxicity. This study will examine the pharmacokinetics, elimination, and metabolism of AZT in patients with liver disease. Guidelines developed from the data will be helpful in managing AZT treatment of these HIV-infected persons and will indicate whether the dose of AZT administered should be adjusted to compensate for any changes in its bioavailability and/or pharmacokinetics.
Interventions
- DRUG Zidovudine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Est. Completion | 1990-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001001
The ClinicalTrials.gov registry entry for NCT00001001 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 39 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Zidovudine is the first listed.
NCT00001001 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001001 about?
NCT00001001 is a clinical study titled "A Study of Zidovudine in HIV-Infected Patients With Liver Disease". To examine the pharmacokinetics (blood levels) and bioavailability of zidovudine (AZT) given to patients with HIV infection and chronic liver disease. The specific aim of the study is to provide data permitting the development of guidelines for use of AZT in patients with mild, moderate, or severe l...
What is the current status of trial NCT00001001?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. Estimated completion is 1990-05.
What interventions are being tested in trial NCT00001001?
The interventions under investigation include: Zidovudine (DRUG).
Who is sponsoring clinical trial NCT00001001?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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