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NCT00000655 · ClinicalTrials.gov registry record · Phase 2

A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients

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

Completed
Registry status
Phase 2
Development phase
300
Enrollment target

NCT00000655: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000655 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 300 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000655, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 2
Development phase
300 participants
Enrollment target

Study Summary

To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients with an acute episode of PCP. Standard therapies for acute treatment of PCP involve either SMX/TMP or pentamidine isetionate. Although both treatments are equally effective, side effects prevent completion of therapy in 11-55 percent of patients.

Interventions

  • DRUG Atovaquone
  • DRUG Sulfamethoxazole-Trimethoprim

Trial Details

FieldValue
Enrollment Target 300 participants
Phase Phase 2

What the finished NCT00000655 record still lists

NCT00000655 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (126% higher).

The record links to 0 conditions, and to 2 interventions - of which Atovaquone is the first listed.

NCT00000655 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000655 about?

NCT00000655 is a clinical study titled "A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients". To evaluate the effectiveness of atovaquone (566C80) compared to a standard antipneumocystis agent, (SMX/TMP), for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients. To compare the safety of short-term (21 days) treatment with 566C80 and SMX/TMP in AIDS patients...

What is the current status of trial NCT00000655?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 300 participants.

What interventions are being tested in trial NCT00000655?

The interventions under investigation include: Atovaquone (DRUG), Sulfamethoxazole-Trimethoprim (DRUG).

Who is sponsoring clinical trial NCT00000655?

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 NCT00000655's enrollment target sits among peer trials

300 167th of 2000 higher than 1,813 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00000655, the US trial registry maintained by the National Library of Medicine. NCT00000655 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.