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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Page 1 of 12 (46 locations)

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