A Phase 3 interventional study of Atovaquone and Dapsone in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 44 sites in 2 countries. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 3, Interventional, and Treatment
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.
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.
Patients are randomized to receive either dapsone or atovaquone daily, with follow-up at the clinic every 4 months.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 700 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,401 studies on the registry; 179 are open to participants now.
Of its 396 completed or terminated interventional studies of FDA-regulated products, 294 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Concurrent Medication: Strongly recommended:
Patients must have:
NOTE:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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National Institute of Allergy and Infectious Diseases (NIAID)