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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 receive oral dapsone in a lower dose once daily or at a higher dose once weekly. Treatment continues until the last patient enrolled has received at least 3 months of therapy. Blood samples are drawn between weeks 4 and 8, at weeks 12 and 24, and every 3 months thereafter during dapsone administration.

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

Conditions
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Pneumonia, Pneumocystis Carinii, HIV Infections

Intervention / Treatment
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* Drug: Dapsone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dapsone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule