Squamous cell carcinoma invading the right temporomandibular joint in a Belgian mare.
Melanie Perrier, Tobias Schwarz, Olga Gonzalez...
https://pubmed.ncbi.nlm.nih.gov/21037891Completed
Phase 1
Age: 1Month - 12Years
All Genders
ID00000739
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
96
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
J
Jacobus Pharmaceutical
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis Carinii Pneumonia in Pediatric HIV Infection
Who Can Participate
Age: 1Month - 12Years
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 46 locations
1
Long Beach Memorial Med. Ctr., Miller Children's Hosp.
Long Beach, California, United States, 90801
Status Unknown
2
Usc La Nichd Crs
Los Angeles, California, United States, 90033
Status Unknown
3
UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS
Los Angeles, California, United States, 90095
Status Unknown
4
Children's Hosp. & Research Ctr. Oakland, Ped. Clinical Research Ctr. & Research Lab.
Oakland, California, United States, 94609
Status Unknown
5
UCSD Maternal, Child, and Adolescent HIV CRS
San Diego, California, United States, 92093
Status Unknown
6
Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases
Torrance, California, United States, 90502
Status Unknown
7
Univ. of Colorado Denver NICHD CRS
Aurora, Colorado, United States, 80218
Status Unknown
8
Children's National Med. Ctr., ACTU
Washington D.C., District of Columbia, United States, 20010
Status Unknown
9
Howard Univ. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States, 20060
Status Unknown
10
Univ. of Florida Jacksonville NICHD CRS
Jacksonville, Florida, United States, 32209
Status Unknown
11
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States, 33161
Status Unknown
12
Emory Univ. School of Medicine, Dept. of Peds., Div. of Infectious Diseases
Atlanta, Georgia, United States, 30306
Status Unknown
13
Cook County Hosp.
Chicago, Illinois, United States, 60612
Status Unknown
14
Chicago Children's CRS
Chicago, Illinois, United States, 60614
Status Unknown
15
Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease
Chicago, Illinois, United States, 60637
Status Unknown
16
Univ. of Illinois College of Medicine at Chicago, Dept. of Peds
Chicago, Illinois, United States
Status Unknown
17
Tulane/LSU Maternal/Child CRS
New Orleans, Louisiana, United States, 70112
Status Unknown
18
HMS - Children's Hosp. Boston, Div. of Infectious Diseases
Boston, Massachusetts, United States, 02115
Status Unknown
19
BMC, Div. of Ped Infectious Diseases
Boston, Massachusetts, United States, 02118
Status Unknown
20
Baystate Health, Baystate Med. Ctr.
Springfield, Massachusetts, United States, 01199
Status Unknown
21
WNE Maternal Pediatric Adolescent AIDS CRS
Worcester, Massachusetts, United States, 01655
Status Unknown
22
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States, 48201
Status Unknown
23
UMDNJ - Robert Wood Johnson
New Brunswick, New Jersey, United States, 08903
Status Unknown
24
St. Joseph's Hosp. & Med. Ctr. of New Jersey
Paterson, New Jersey, United States, 07103
Status Unknown
25
SUNY Downstate Med. Ctr., Children's Hosp. at Downstate NICHD CRS
Brooklyn, New York, United States, 11203
Status Unknown
26
North Shore-Long Island Jewish Health System, Dept. of Peds.
Great Neck, New York, United States, 11021
Status Unknown
27
Schneider Children's Hosp., Div. of Infectious Diseases
New Hyde Park, New York, United States, 11040
Status Unknown
28
NYU Med. Ctr., Dept. of Medicine
New York, New York, United States, 10016
Status Unknown
29
Columbia IMPAACT CRS
New York, New York, United States, 10032
Status Unknown
30
Incarnation Children's Ctr.
New York, New York, United States, 10032
Status Unknown
31
Harlem Hosp. Ctr. NY NICHD CRS
New York, New York, United States, 10037
Status Unknown
32
Univ. of Rochester ACTG CRS
Rochester, New York, United States, 14642
Status Unknown
33
Strong Memorial Hospital Rochester NY NICHD CRS
Rochester, New York, United States
Status Unknown
34
SUNY Stony Brook NICHD CRS
Stony Brook, New York, United States, 11794
Status Unknown
35
SUNY Upstate Med. Univ., Dept. of Peds.
Syracuse, New York, United States, 13210
Status Unknown
36
DUMC Ped. CRS
Durham, North Carolina, United States, 27710
Status Unknown
37
Case CRS
Cleveland, Ohio, United States
Status Unknown
38
The Children's Hosp. of Philadelphia IMPAACT CRS
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
39
St. Christopher's Hosp. for Children
Philadelphia, Pennsylvania, United States, 19134
Status Unknown
40
Med. Univ. of South Carolina, Div. of Ped. Infectious Diseases
Charleston, South Carolina, United States, 2942
Status Unknown
41
St. Jude/UTHSC CRS
Memphis, Tennessee, United States, 38105
Status Unknown
42
Childrens Hosp. of the Kings Daughters
Norfolk, Virginia, United States, 23507
Status Unknown
43
UW School of Medicine - CHRMC
Seattle, Washington, United States, 98105
Status Unknown
44
Univ. Hosp. Ramón Ruiz Arnau, Dept. of Peds
Bayamón, Puerto Rico
Status Unknown
45
San Juan City Hosp. PR NICHD CRS
San Juan, Puerto Rico, 00936
Status Unknown
46
Univ. of Puerto Rico Ped. HIV/AIDS Research Program CRS
San Juan, Puerto Rico
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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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.
K McIntosh, E Cooper, J Xu...
https://pubmed.ncbi.nlm.nih.gov/10353516