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NCT00001018 · ClinicalTrials.gov registry record · Phase 1

A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea

A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
32
Enrollment target

NCT00001018 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 32 participants.

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The verdict

NCT00001018, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
32 participants
Enrollment target

Study Summary

To determine the pharmacokinetic profile of single doses of letrazuril in patients with AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to evaluate the safety and efficacy of escalating doses of letrazuril, compared with placebo, for patients with AIDS-related cryptosporidial diarrhea. Letrazuril, the p-fluor analog of diclazuril, has been shown in an animal model to prevent infections by organisms closely related to the intracellular parasite Cryptosporidium. Reliable data are needed to show the effectiveness of letrazuril in treating AIDS-related cryptosporidial diarrhea.

Interventions

  • DRUG Letrazuril

Trial Details

FieldValue
Enrollment Target 32 participants
Phase Phase 1

What the Registry Record Tells You About NCT00001018

The ClinicalTrials.gov registry entry for NCT00001018 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 32 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 Letrazuril is the first listed.

NCT00001018 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001018 about?

NCT00001018 is a clinical study titled "A Study of Letrazuril in the Treatment of AIDS-Related Diarrhea". To determine the pharmacokinetic profile of single doses of letrazuril in patients with AIDS-related cryptosporidial diarrhea; to determine the dose proportionality of single escalating doses of letrazuril; to determine steady-state concentrations of letrazuril; to evaluate the safety and efficacy o...

What is the current status of trial NCT00001018?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants.

What interventions are being tested in trial NCT00001018?

The interventions under investigation include: Letrazuril (DRUG).

Who is sponsoring clinical trial NCT00001018?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.