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NCT00000794 · ClinicalTrials.gov registry record · Phase 2

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis

A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 2
Development phase
100
Enrollment target

NCT00000794 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants.

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The verdict

NCT00000794, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
100 participants
Enrollment target

Study Summary

To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied.

Interventions

  • DRUG Atovaquone
  • DRUG Leucovorin calcium
  • DRUG Pyrimethamine
  • DRUG Sulfadiazine
  • DRUG Clarithromycin

Trial Details

FieldValue
Enrollment Target 100 participants
Est. Completion 1998-04
Phase Phase 2

What the Registry Record Tells You About NCT00000794

The ClinicalTrials.gov registry entry for NCT00000794 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 5 interventions - of which Atovaquone is the first listed.

NCT00000794 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000794 about?

NCT00000794 is a clinical study titled "Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis". To evaluate the efficacy, safety, and tolerance of atovaquone with either pyrimethamine or sulfadiazine in AIDS patients with toxoplasmic encephalitis. AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high freque...

What is the current status of trial NCT00000794?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. Estimated completion is 1998-04.

What interventions are being tested in trial NCT00000794?

The interventions under investigation include: Atovaquone (DRUG), Leucovorin calcium (DRUG), Pyrimethamine (DRUG), Sulfadiazine (DRUG), Clarithromycin (DRUG).

Who is sponsoring clinical trial NCT00000794?

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.