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NCT00000640 · ClinicalTrials.gov registry record · Phase 3

A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS

A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 3
Development phase
290
Enrollment target

NCT00000640: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000640 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 290 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000640, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 3
Development phase
290 participants
Enrollment target

Study Summary

To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treatments as compared to the standard treatment of SMX/TMP. Per 09/09/92 amendment, to assess the efficacy and tolerance of these two alternative treatments in patients who are intolerant to SMX/TMP. The type of treatment being studied has the advantages of wide applicability throughout the world (including developing countries) and low cost. An oral treatment is more accessible to patients than drugs given by injection or by inhalation.

Interventions

  • DRUG Dapsone
  • DRUG Clindamycin
  • DRUG Sulfamethoxazole-Trimethoprim
  • DRUG Primaquine

Trial Details

FieldValue
Enrollment Target 290 participants
Est. Completion 1994-09
Phase Phase 3

What the finished NCT00000640 record still lists

NCT00000640 is an interventional study that assigns participants to a tested intervention. The registered 290 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower).

The record links to 0 conditions, and to 4 interventions - of which Dapsone is the first listed.

NCT00000640 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000640 about?

NCT00000640 is a clinical study titled "A Phase III Comparative Study of Dapsone / Trimethoprim and Clindamycin / Primaquine Versus Sulfamethoxazole / Trimethoprim in the Treatment of Mild-to-Moderate PCP in Patients With AIDS". To evaluate the effectiveness of two oral treatments for mild to moderate Pneumocystis carinii pneumonia (PCP): dapsone/trimethoprim or clindamycin/primaquine as compared to a standard treatment program of sulfamethoxazole/trimethoprim (SMX/TMP) to assess the tolerance of these two alternative treat...

What is the current status of trial NCT00000640?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 290 participants. Estimated completion is 1994-09.

What interventions are being tested in trial NCT00000640?

The interventions under investigation include: Dapsone (DRUG), Clindamycin (DRUG), Sulfamethoxazole-Trimethoprim (DRUG), Primaquine (DRUG).

Who is sponsoring clinical trial NCT00000640?

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 NCT00000640's enrollment target sits among peer trials

290 1171st of 2000 higher than 828 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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 NCT00000640, the US trial registry maintained by the National Library of Medicine. NCT00000640 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.