Status:
COMPLETED
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Jacobus Pharmaceutical
Conditions:
Pneumonia, Pneumocystis Carinii
HIV Infections
Eligibility:
All Genders
1-12 years
Phase:
PHASE1
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....
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 /...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
June 1 1998
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00000739
End Date
June 1 1998
Last Update
November 4 2021
Active Locations (46)
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1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609