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NCT00000739 · ClinicalTrials.gov registry record · Phase 1

Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection

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

Completed
Registry status
Phase 1
Development phase
96
Enrollment target

NCT00000739: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

NCT00000739 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 96 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000739, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
96 participants
Enrollment target

Study Summary

Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone. Prophylaxis for Pneumocystis carinii pneumonia ( PCP ) is recommended for all HIV-infected children considered to be at high risk. Approximately 15 percent of children are intolerant to trimethoprim / sulfamethoxazole, the first choice drug for PCP prophylaxis. Since many children are also unable to take or tolerate aerosolized pentamidine, dapsone is a second choice for PCP prophylaxis. The most favorable dose regimen for dapsone has not been established.

Interventions

  • DRUG Dapsone

Trial Details

FieldValue
Enrollment Target 96 participants
Est. Completion 1998-06
Phase Phase 1

What the finished NCT00000739 record still lists

NCT00000739 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% higher).

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

NCT00000739 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000739 about?

NCT00000739 is a clinical study titled "Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection". Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children. Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthroug...

What is the current status of trial NCT00000739?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. Estimated completion is 1998-06.

What interventions are being tested in trial NCT00000739?

The interventions under investigation include: Dapsone (DRUG).

Who is sponsoring clinical trial NCT00000739?

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 NCT00000739's enrollment target sits among peer trials

96 600th of 2000 higher than 1,391 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 NCT00000739, the US trial registry maintained by the National Library of Medicine. NCT00000739 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.