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A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole 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 A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole Clinical research trials and A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole 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 A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole. A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole 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 A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole clinical trial. Subjects frequently get the best healthcare possible for their A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole 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 > "A" Clinical Trials Conditions > A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole  A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Fujisawa Pharmaceutical
Synopsis: Primary: To compare the pharmacokinetics of biweekly and monthly dose regimens of intravenous pentamidine in HIV-infected infants and children who require PCP prophylaxis and who are intolerant to oral trimethoprim - sulfamethoxazole. To determine the safety and tolerance of these regimens in this patient population. Secondary: To obtain information on the rate of PCP breakthrough in infants and children receiving parenteral pentamidine prophylaxis. Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative.
Details: Prophylaxis against Pneumocystis carinii pneumonia is recommended for all HIV-infected children considered to be at high risk. In children younger than 5 years of age with intolerance to trimethoprim - sulfamethoxazole, parenteral pentamidine may be a successful alternative. Thirty-two children are randomized to one of two treatment arms. Patients receive pentamidine on either a biweekly or a monthly treatment schedule. Treatment continues until the last child enrolled has received at least 6 months of pentamidine. Patients are stratified according to age < 24 months or age >= 24 months. Steady-state pharmacokinetics will be examined in a subsample of 20 patients.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Month/6 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Steroids and intravenous immune globulin (IVIG). Patients must have: - Documented HIV infection. - Need for PCP prophylaxis. - Known intolerance to trimethoprim - sulfamethoxazole (TMP-SMX). One of the following required conditions: - Known intolerance or allergy to dapsone; G6PD deficiency; history of serious or life-threatening reaction to TMP-SMX; exclusion from protocol ACTG 179; election by parent not to enroll child on ACTG 179; or receiving medical care at sites not participating in ACTG 179. NOTE: - Co-enrollment in other ACTG pediatric studies is permitted. Consent of parent or guardian is required. Prior Medication: Allowed: - Prior pentamidine. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: - Active PCP. - Pancreatitis defined as amylase elevation associated with an elevated lipase that is > 2 x upper limit of normal. Prior Medication: Excluded: - TMP-SMX or dapsone within 7 days prior to study entry (toxicities to TMP-SMX or dapsone must be clearly resolving).
Total Enrollment: 32
Location and Contact Information:
Overall Study Official:
VanR, Study Chair,
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Children's Hosp Pact Prog / Children's Hosp of Buffalo
Buffalo, New York, 14222
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Mount Sinai Med Ctr
New York City, New York, 10029
United States
Harlem Hosp Ctr
New York City, New York, 10037
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Additional Information:
Study ID Numbers: ACTG 189;
Study Start Date:
Record last reviewed: October 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001027
Other Pneumonia, Pneumocystis Carinii Studies:
1. Aerosols in the Treatment of Pneumocystis Pneumonia: A Pilot Study Quantitating the Deposition of Aerosolized Pentamidine as Delivered in ACTG 040 and Comparing Its Toxicity With Parenteral Pentamidine Therapy
2. A Study of Trimetrexate in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS Not Previously Treated for PCP
3. Comparison of Trimetrexate Plus Leucovorin Calcium Rescue Versus Sulfamethoxazole-Trimethoprim in the Treatment of Pneumocystis carinii Pneumonia (PCP) in Patients with AIDS
4. Comparison of Two Dosage Regimens of Oral Dapsone for Prophylaxis of Pneumocystis carinii Pneumonia in Pediatric HIV Infection
5. A Randomized, Double-Blind Study of 566C80 Versus Septra (Sulfamethoxazole/Trimethoprim) for the Treatment of Pneumocystis carinii Pneumonia in AIDS Patients
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Other Pneumonia, Pneumocystis carinii Clinical Trials
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A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in HIV-Infected Children Who Cannot Take Trimethoprim-Sulfamethoxazole
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