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NCT00000802 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 700
- Enrollment target
NCT00000802: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000802 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 700 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000802, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 700 participants
- Enrollment target
Study Summary
To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to trimethoprim and/or sulfonamides. Trimethoprim/sulfamethoxazole (TMP/SMX), which is effective for secondary PCP prophylaxis, is associated with allergic manifestations and side effects that limit its use. Patients who are intolerant of TMP/SMX require an effective alternative. Dapsone and atovaquone have both shown promise as PCP prophylactic agents.
Interventions
- DRUG Atovaquone
- DRUG Dapsone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Est. Completion | 1997-07 |
| Phase | Phase 3 |
What the finished NCT00000802 record still lists
NCT00000802 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Atovaquone is the first listed.
NCT00000802 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00000802 about?
NCT00000802 is a clinical study titled "A Randomized, Comparative Study of Daily Dapsone and Daily Atovaquone for Prophylaxis Against PCP in HIV-Infected Patients Who Are Intolerant of Trimethoprim and/or Sulfonamides". To compare the efficacy and safety of dapsone versus atovaquone in preventing or delaying the onset of histologically proven or probable Pneumocystis carinii pneumonia in HIV-infected patients with CD4 counts \<= 200 cells/mm3 or \<= 15 percent of the total lymphocyte count who are intolerant to tri...
What is the current status of trial NCT00000802?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 700 participants. Estimated completion is 1997-07.
What interventions are being tested in trial NCT00000802?
The interventions under investigation include: Atovaquone (DRUG), Dapsone (DRUG).
Who is sponsoring clinical trial NCT00000802?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00000802's enrollment target sits among peer trials
700 506th of 2000 higher than 1,485 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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