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

Completed · Phase 1

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000739

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

96

Expected to finish

1998-06-01

Last updated by the study team

2021-11-04

Who can join

Age: 0 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Long Beach Memorial Med. Ctr., Miller Children's Hosp. — Long Beach, California, United States
• Usc La Nichd Crs — Los Angeles, California, United States
• UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS — Los Angeles, California, United States
• Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab. — Oakland, California, United States
• UCSD Maternal, Child, and Adolescent HIV CRS — San Diego, California, United States
• Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases — Torrance, California, United States
• Univ. of Colorado Denver NICHD CRS — Aurora, Colorado, United States
• Children's National Med. Ctr., ACTU — Washington D.C., District of Columbia, United States
• Howard Univ. Washington DC NICHD CRS — Washington D.C., District of Columbia, United States
• Univ. of Florida Jacksonville NICHD CRS — Jacksonville, Florida, United States
• Univ. of Miami Ped. Perinatal HIV/AIDS CRS — Miami, Florida, United States
• Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases — Atlanta, Georgia, United States
• Cook County Hosp. — Chicago, Illinois, United States
• Chicago Children's CRS — Chicago, Illinois, United States
• Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease — Chicago, Illinois, United States
• Univ. of Illinois College of Medicine at Chicago, Dept. of Peds — Chicago, Illinois, United States
• Tulane/LSU Maternal/Child CRS — New Orleans, Louisiana, United States
• HMS - Children's Hosp. Boston, Div. of Infectious Diseases — Boston, Massachusetts, United States
• BMC, Div. of Ped Infectious Diseases — Boston, Massachusetts, United States
• Baystate Health, Baystate Med. Ctr. — Springfield, Massachusetts, United States
• WNE Maternal Pediatric Adolescent AIDS CRS — Worcester, Massachusetts, United States
• Children's Hospital of Michigan NICHD CRS — Detroit, Michigan, United States
• UMDNJ - Robert Wood Johnson — New Brunswick, New Jersey, United States
• St. Joseph's Hosp. & Med. Ctr. of New Jersey — Paterson, New Jersey, United States
• SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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