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

Information source: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections

Intervention: Dapsone (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)

Official(s) and/or principal investigator(s):
McIntosh K, Study Chair
Cooper E, Study Chair

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.

Clinical Details

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

Study design: Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

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.

Eligibility

Minimum age: 1 Month. Maximum age: 12 Years. Gender(s): Both.

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.

Locations and Contacts

Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds, Bayamon, Puerto Rico

San Juan City Hosp. PR NICHD CRS, San Juan 00936, Puerto Rico

Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS, San Juan, Puerto Rico

Long Beach Memorial Med. Ctr., Miller Children's Hosp., Long Beach, California 90801, United States

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles, California 90095, United States

Usc La Nichd Crs, Los Angeles, California 90033, United States

Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab., Oakland, California 94609, United States

UCSD Maternal, Child, and Adolescent HIV CRS, San Diego, California 92093, United States

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases, Torrance, California 90502, United States

Univ. of Colorado Denver NICHD CRS, Aurora, Colorado 80218, United States

Children's National Med. Ctr., ACTU, Washington, District of Columbia 20010, United States

Howard Univ. Washington DC NICHD CRS, Washington, District of Columbia 20060, United States

Univ. of Florida Jacksonville NICHD CRS, Jacksonville, Florida 32209, United States

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami, Florida 33161, United States

Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases, Atlanta, Georgia 30306, United States

Chicago Children's CRS, Chicago, Illinois 60614, United States

Cook County Hosp., Chicago, Illinois 60612, United States

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago, Illinois 60637, 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 70112, United States

BMC, Div. of Ped Infectious Diseases, Boston, Massachusetts 02118, United States

HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston, Massachusetts 02115, United States

Baystate Health, Baystate Med. Ctr., Springfield, Massachusetts 01199, United States

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester, Massachusetts 01655, United States

Children's Hospital of Michigan NICHD CRS, Detroit, Michigan 48201, United States

UMDNJ - Robert Wood Johnson, New Brunswick, New Jersey 08903, United States

St. Joseph's Hosp. & Med. Ctr. of New Jersey, Paterson, New Jersey 07103, United States

SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS, Brooklyn, New York 11203, United States

North Shore-Long Island Jewish Health System, Dept. of Peds., Great Neck, New York 11021, United States

Schneider Children's Hosp., Div. of Infectious Diseases, New Hyde Park, New York 11040, United States

Columbia IMPAACT CRS, New York, New York 10032, United States

Harlem Hosp. Ctr. NY NICHD CRS, New York, New York 10037, United States

Incarnation Children's Ctr., New York, New York 10032, United States

NYU Med. Ctr., Dept. of Medicine, New York, New York 10016, United States

Strong Memorial Hospital Rochester NY NICHD CRS, Rochester, New York, United States

Univ. of Rochester ACTG CRS, Rochester, New York 14642, United States

SUNY Stony Brook NICHD CRS, Stony Brook, New York 11794, United States

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse, New York 13210, United States

DUMC Ped. CRS, Durham, North Carolina 27710, United States

Case CRS, Cleveland, Ohio, United States

St. Christopher's Hosp. for Children, Philadelphia, Pennsylvania 19134, United States

The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia, Pennsylvania 19104, United States

Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases, Charleston, South Carolina 2942, United States

St. Jude/UTHSC CRS, Memphis, Tennessee 38105, United States

Childrens Hosp. of the Kings Daughters, Norfolk, Virginia 23507, United States

UW School of Medicine - CHRMC, Seattle, Washington 98105, United States

Additional Information

Related publications:

Mirochnick M, Cooper E, McIntosh K. Pharmacokinetics of daily and weekly dapsone in HIV-infected children. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:159

Mirochnick M, Cooper E, Mcintosh K. Pharmacokinetics of daily and weekly dapsone in HIV-infected children. ACTG Protocol 179 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)

Perrier M, Schwarz T, Gonzalez O, Brounts S. Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare. Can Vet J. 2010 Aug;51(8):885-7.

McIntosh K, Cooper E, Xu J, Mirochnick M, Lindsey J, Jacobus D, Mofenson L, Yogev R, Spector SA, Sullivan JL, Sacks H, Kovacs A, Nachman S, Sleasman J, Bonagura V, McNamara J. Toxicity and efficacy of daily vs. weekly dapsone for prevention of Pneumocystis carinii pneumonia in children infected with human immunodeficiency virus. ACTG 179 Study Team. AIDS Clinical Trials Group. Pediatr Infect Dis J. 1999 May;18(5):432-9.


Last updated: March 30, 2012

Page last updated: August 23, 2015

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