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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication: Strongly recommended:
• • Pyrimethamine (50 mg) and folinic acid (15 mg) weekly in patients receiving dapsone who have CD4 count \< 100 cells/mm3 and are toxoplasmosis seropositive.
• Patients must have:
• • Working diagnosis of HIV infection.
• • CD4 count \<= 200 cells/mm3 or \<= 15 percent of total lymphocyte count at any time in the past OR a history of PCP.
• • History of intolerance of trimethoprim and/or sulfonamides that required permanent discontinuation.
• NOTE:
• • Pregnant patients are eligible at the clinician's discretion.
• Prior Medication:
• Allowed:
• • Prior PCP prophylaxis.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Active pneumocystosis.
• Concurrent Medication:
• Excluded:
• • PCP prophylaxis (other than study drug) or any medication with potential anti-PCP activity.
• Patients with the following prior conditions are excluded:
• • Known treatment-limiting reaction to dapsone or atovaquone.

Trial Officials