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

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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00001018 record still lists

NCT00001018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).

The record links to 0 conditions, and to 1 intervention - of which Letrazuril is the first listed.

NCT00001018 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00001018's enrollment target sits among peer trials

32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00001018, the US trial registry maintained by the National Library of Medicine. NCT00001018 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.