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

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Dapsone
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule

Eligibility Criteria

1 Month - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Long Beach Memorial Med. Ctr., Miller Children's Hosp.
  • Usc La Nichd Crs
  • UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
  • Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
  • UCSD Maternal, Child, and Adolescent HIV CRS
  • Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
  • Univ. of Colorado Denver NICHD CRS
  • Children's National Med. Ctr., ACTU
  • Howard Univ. Washington DC NICHD CRS
  • Univ. of Florida Jacksonville NICHD CRS
  • Univ. of Miami Ped. Perinatal HIV/AIDS CRS
  • Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
  • Cook County Hosp.
  • Chicago Children's CRS
  • Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
  • Univ. of Illinois College of Medicine at Chicago, Dept. of Peds
  • Tulane/LSU Maternal/Child CRS
  • HMS - Children's Hosp. Boston, Div. of Infectious Diseases
  • BMC, Div. of Ped Infectious Diseases
  • Baystate Health, Baystate Med. Ctr.
  • WNE Maternal Pediatric Adolescent AIDS CRS
  • Children's Hospital of Michigan NICHD CRS
  • UMDNJ - Robert Wood Johnson
  • St. Joseph's Hosp. & Med. Ctr. of New Jersey
  • SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
  • North Shore-Long Island Jewish Health System, Dept. of Peds.
  • Schneider Children's Hosp., Div. of Infectious Diseases
  • NYU Med. Ctr., Dept. of Medicine
  • Columbia IMPAACT CRS
  • Incarnation Children's Ctr.
  • Harlem Hosp. Ctr. NY NICHD CRS
  • Univ. of Rochester ACTG CRS
  • Strong Memorial Hospital Rochester NY NICHD CRS
  • SUNY Stony Brook NICHD CRS
  • SUNY Upstate Med. Univ., Dept. of Peds.
  • DUMC Ped. CRS
  • Case CRS
  • The Children's Hosp. of Philadelphia IMPAACT CRS
  • St. Christopher's Hosp. for Children
  • Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
  • St. Jude/UTHSC CRS
  • Childrens Hosp. of the Kings Daughters
  • UW School of Medicine - CHRMC
  • Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds
  • San Juan City Hosp. PR NICHD CRS
  • Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Jacobus Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT00000739
Brief Title
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Official Title
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1998 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Jacobus Pharmaceutical

4. Oversight

5. Study Description

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. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
Pneumonia, Pneumocystis carinii, Dapsone, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Drug Administration Schedule

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Enrollment
96 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dapsone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McIntosh K
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cooper E
Official's Role
Study Chair
Facility Information:
Facility Name
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Usc La Nichd Crs
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UCSD Maternal, Child, and Adolescent HIV CRS
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Univ. of Colorado Denver NICHD CRS
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Children's National Med. Ctr., ACTU
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard Univ. Washington DC NICHD CRS
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Univ. of Florida Jacksonville NICHD CRS
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Cook County Hosp.
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's CRS
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Tulane/LSU Maternal/Child CRS
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
BMC, Div. of Ped Infectious Diseases
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Health, Baystate Med. Ctr.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
WNE Maternal Pediatric Adolescent AIDS CRS
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Children's Hospital of Michigan NICHD CRS
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
St. Joseph's Hosp. & Med. Ctr. of New Jersey
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
North Shore-Long Island Jewish Health System, Dept. of Peds.
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Schneider Children's Hosp., Div. of Infectious Diseases
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Med. Ctr., Dept. of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia IMPAACT CRS
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Incarnation Children's Ctr.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Harlem Hosp. Ctr. NY NICHD CRS
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Univ. of Rochester ACTG CRS
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Strong Memorial Hospital Rochester NY NICHD CRS
City
Rochester
State/Province
New York
Country
United States
Facility Name
SUNY Stony Brook NICHD CRS
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Med. Univ., Dept. of Peds.
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
DUMC Ped. CRS
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case CRS
City
Cleveland
State/Province
Ohio
Country
United States
Facility Name
The Children's Hosp. of Philadelphia IMPAACT CRS
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
St. Christopher's Hosp. for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
2942
Country
United States
Facility Name
St. Jude/UTHSC CRS
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Childrens Hosp. of the Kings Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
UW School of Medicine - CHRMC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds
City
Bayamon
Country
Puerto Rico
Facility Name
San Juan City Hosp. PR NICHD CRS
City
San Juan
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
City
San Juan
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
21037891
Citation
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.
Results Reference
background
PubMed Identifier
10353516
Citation
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.
Results Reference
background

Learn more about this trial

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

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