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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000802
The ClinicalTrials.gov registry entry for NCT00000802 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Atovaquone is the first listed.
NCT00000802 reports 0 study locations.
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.
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