HIV Infections, Pneumonia, Pneumocystis Carinii
Conditions
Keywords
Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule
Brief 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.
Detailed description
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.
Interventions
DRUGDapsone
Sponsors
Jacobus Pharmaceutical
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Years
Healthy volunteers
No
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.
Countries
Puerto Rico, United States
Outcome results
None listed