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

• Status: Completed
• Trial end date: 1998-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary: To compare the toxicity of daily versus weekly dapsone in HIV-infected infants and children; to study the pharmacokinetics of orally administered dapsone in HIV-infected infants and children.

Secondary: To obtain information on the rate of Pneumocystis carinii pneumonia ( PCP ) breakthrough in children receiving two different dose regimens of dapsone.

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Collaborator: Jacobus Pharmaceutical
• Treatments: Dapsone

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.