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

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

Keywords

ClinConnect Summary

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.

Ninety-six HIV-infected infants and children who are intolerant to trimethoprim / sulfamethoxazole ( TMP / SMX ) are randomized to rece...

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Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Allowed:
• • Rifampin and rifampin derivatives for up to 1 week during the study.
• • Rifabutin or other drugs that could alter dapsone metabolism (if prescribed by the child's primary care physician).
• Patients must have:
• • Evidence of HIV infection.
• PER AMENDMENT 11/16/95:
• • Children who require prophylaxis. (Was written - Risk of developing PCP.)
• • Known intolerance to TMP / SMX.
• • Consent of parent or guardian. Patients entering this study may be co-enrolled in other ACTG pediatric studies.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Glucose-6-phosphate dehydrogenase deficiency.
• • Known allergy to dapsone.
• Concurrent Medication:
• Excluded:
• • Rifampin, rifampin derivatives, or oxidant drugs for more than 1 week.
• Patients with the following prior conditions are excluded:
• • Serious or life-threatening reactions to TMP / SMX (e.g., anaphylaxis, Stevens-Johnson syndrome, hypotension) that would contraindicate therapy with sulfa drugs.
• Prior Medication:
• Excluded:
• • Prior dapsone.
• • Rifampin, rifampin derivatives, or oxidant drugs within 1 week prior to study entry.
• • TMP / SMX within 7 days prior to study entry (and toxicity must be clearly resolving).
• Prior Treatment:
• Excluded:
• • RBC transfusion within 4 weeks prior to study entry.