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

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.