Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
NCT ID: NCT00000739
Last Updated: 2021-11-04
Study Results
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Basic Information
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COMPLETED
PHASE1
96 participants
INTERVENTIONAL
1998-06-30
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Dapsone
Eligibility Criteria
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Inclusion Criteria
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
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.
1 Month
12 Years
ALL
No
Sponsors
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Jacobus Pharmaceutical
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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McIntosh K
Role: STUDY_CHAIR
Cooper E
Role: STUDY_CHAIR
Locations
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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
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States
Columbia IMPAACT CRS
New York, New York, United States
Incarnation Children's Ctr.
New York, New York, United States
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States
Univ. of Rochester ACTG CRS
Rochester, New York, United States
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States
DUMC Ped. CRS
Durham, North Carolina, United States
Case CRS
Cleveland, Ohio, United States
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
Childrens Hosp. of the Kings Daughters
Norfolk, Virginia, United States
UW School of Medicine - CHRMC
Seattle, Washington, United States
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds
Bayamón, , Puerto Rico
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, , Puerto Rico
Countries
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References
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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. doi: 10.1097/00006454-199905000-00007.
Other Identifiers
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11154
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 179
Identifier Type: -
Identifier Source: org_study_id