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Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection Clinical research trials and Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection clinical trial. Subjects frequently get the best healthcare possible for their Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): Jacobus Pharmaceutical , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Parallel Assignment, Pharmacokinetics Study
Minimum Age/Maximum Age: 1 Month/12 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 96
Location and Contact Information:
Overall Study Official:
McIntoshK, Study Chair,
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Incarnation Children's Ctr / Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Cincinnati Children's Hosp / Univ Hosp
Cincinnati, Ohio, 452292899
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
King's County Hosp Ctr / Pediatrics
Brooklyn, New York, 11203
United States
Emory Univ Hosp / Pediatrics
Atlanta, Georgia, 30306
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Oakland
Oakland, California, 946091809
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Schneider Children's Hosp
New Hyde Park, New York, 11040
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Mem Sloan - Kettering Cancer Ctr
New York City, New York, 10021
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Additional Information:
Study ID Numbers: ACTG 179;
Study Start Date:
Record last reviewed: November 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000739
Other Pneumonia, Pneumocystis Carinii Studies:
1. Randomized Phase I Study of Trimetrexate Glucuronate (TMTX) With Leucovorin (LCV) Protection Plus Dapsone Versus Trimethoprim / Sulfamethoxazole (TMP/SMX) for Treatment of Moderately Severe Episodes of Pneumocystis carinii Pneumonia
2. An Open, Prospective, Multicenter Study of Trimetrexate With Leucovorin Rescue for AIDS Patients With Pneumocystis carinii Pneumonia (PCP) and Serious Intolerance to Approved Therapies
3. A Study to Compare Different Drugs Used to Prevent Serious Bacterial Infections in HIV-Positive Children
4. A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
5. A Compassionate Treatment Protocol for the Use of Trimetrexate Glucuronate (Neutrexin) With Leucovorin Protection for European Adult Patients (>= 13 Years Old) With Pneumocystis carinii Pneumonia
Related Studies:
Other Pneumonia, Pneumocystis carinii Clinical Trials
Other New York Clinical Trials
Other Stony Brook Clinical Trials
Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
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