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NCT00000973 · ClinicalTrials.gov registry record · Phase 1

A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients

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

Completed
Registry status
Phase 1
Development phase
26
Enrollment target

NCT00000973: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000973 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 26 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000973, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target

Study Summary

To determine the manner in which pyrimethamine is metabolized and excreted in patients currently receiving zidovudine (AZT). An important goal of this measurement is to establish the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in AIDS patients or delay the subsequent return of toxoplasmic encephalitis. Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. The best treatment for this disease has not been determined. Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine.

Interventions

  • DRUG Zidovudine
  • DRUG Leucovorin calcium
  • DRUG Pyrimethamine

Trial Details

FieldValue
Enrollment Target 26 participants
Est. Completion 1995-03
Phase Phase 1

What the finished NCT00000973 record still lists

NCT00000973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (57% lower).

The record links to 0 conditions, and to 3 interventions - of which Zidovudine is the first listed.

NCT00000973 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000973 about?

NCT00000973 is a clinical study titled "A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients". To determine the manner in which pyrimethamine is metabolized and excreted in patients currently receiving zidovudine (AZT). An important goal of this measurement is to establish the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in AIDS patients or delay the sub...

What is the current status of trial NCT00000973?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. Estimated completion is 1995-03.

What interventions are being tested in trial NCT00000973?

The interventions under investigation include: Zidovudine (DRUG), Leucovorin calcium (DRUG), Pyrimethamine (DRUG).

Who is sponsoring clinical trial NCT00000973?

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 NCT00000973's enrollment target sits among peer trials

26 1482nd of 2000 higher than 506 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 NCT00000973, the US trial registry maintained by the National Library of Medicine. NCT00000973 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.