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A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia Clinical research trials and A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia. A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia clinical trial. Test subjects typically receive the most effective healthcare possible for their A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia  A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia
A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia
For Condition: Pneumonia, Pneumocystis carinii,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To evaluate the delivery of a single dose of aerosolized pentamidine to children; to evaluate the tolerance of pentamidine administration by mask; to compare intravenous pentamidine first dose pharmacokinetics (blood levels) in children with information previously collected on adults; and to compare plasma pentamidine levels in children after an aerosolized treatment with levels previously collected on adults. Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with AIDS and is associated with a high death rate. Current approved treatment includes intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which are both effective in treatment of the first episode of PCP pneumonia. However, both therapies have a 50 percent or greater incidence of adverse reactions. Because of serious toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized pentamidine (pentamidine given through inhalation) is as effective as intravenous pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous pentamidine. The study is the first step in evaluating the delivery of aerosolized pentamidine to children.
Details: Pneumocystis carinii pneumonia (PCP) is the most common serious infection in children with AIDS and is associated with a high death rate. Current approved treatment includes intravenous trimethoprim - sulfamethoxazole (TMP / SMX) and intravenous pentamidine, which are both effective in treatment of the first episode of PCP pneumonia. However, both therapies have a 50 percent or greater incidence of adverse reactions. Because of serious toxicities, drug treatment has had to be discontinued. Animal studies show that aerosolized pentamidine (pentamidine given through inhalation) is as effective as intravenous pentamidine. It is hoped that the aerosolized route will be less toxic than intravenous pentamidine. The study is the first step in evaluating the delivery of aerosolized pentamidine to children. Sixteen patients are assigned into one of the following groups. Group 1 (four patients) receives intravenous pentamidine as a one-time dose, infused over 2 hours. Group 2a (six patients) receives aerosolized pentamidine via face mask. Group 2b (six patients) receives aerosolized pentamidine 2 times. Group 2b will be studied only if initial dose is well tolerated. Small amounts (1 - 2 cubic centimeters) of blood is taken from all groups at 40 minutes, and 2, 3, 7, 14, and 24 hours from the beginning of pentamidine treatment and at the same time as the lung biopsy or bronchial alveolar lavage. Patients are given routine TMP / SMX (or whatever medications are considered appropriate by the patient's primary physician for medical management) dosing 1 - 2 hours after pentamidine is given. Bronchial alveolar lavage fluid or lung tissue from biopsy will be obtained between 2 - 48 hours after initiation of pentamidine treatment (optionally 10 - 24 hours post dose).
Eligibility:
Study Type: Interventional, Treatment, Open Label, Pharmacokinetics Study
Minimum Age/Maximum Age: 2 Months/13 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Routine trimethoprim / sulfamethoxazole (TMP / SMX) (or whatever medications are considered appropriate by the patient's primary physician for medical management) 1 - 2 hours after pentamidine is given. Patients must have: - HIV infection with suspected Pneumocystis carinii pneumonia (PCP). - Parent(s) or legal guardian must sign an informed consent. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: - Known history of reactive airway disease or another chronic lung disease. - Known previous adverse reaction to pentamidine. - Thrombocytopenia. Patients with the following are excluded: - History of reactive airway disease or another chronic lung disease. - Known previous adverse reaction to pentamidine. Unable to cooperate with administration of aerosol via face mask.
Total Enrollment: 16
Location and Contact Information:
Overall Study Official:
YJBryson, Study Chair,
Children's Hosp of Oakland
Oakland, California, 946091809
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Cedars Sinai / UCLA Med Ctr
Los Angeles, California, 900481804
United States
Children's Hosp of Los Angeles/UCLA Med Ctr
Los Angeles, California, 900276016
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Additional Information:
Study ID Numbers: ACTG 115;
Study Start Date:
Record last reviewed: March 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000974
Other Pneumonia, Pneumocystis Carinii Studies:
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2. (Ro 24-2027) A Randomized, Double-Blind, Comparative Study of Dideoxycytidine (ddC) versus Zidovudine (AZT) in Patients With AIDS or Advanced ARC
3. A Study to Evaluate the Long-Term Effectiveness of Three Anti-HIV Drug Treatments in HIV-Positive Patients Who Have Never Been Exposed to Highly Active Antiretroviral Therapy (HAART)
4. Neurodevelopmental and Neurological Study of Infants and Children With HIV-1 Infection and AIDS in Clinical Trials
5. A Phase I Safety, Efficacy, and Pharmacokinetic Study of 2',3'-Dideoxyinosine (ddI) Administered Twice Daily to Patients With AIDS or AIDS Related Complex
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A Study of Two Forms of Pentamidine in HIV-Infected Children Who May Have Pneumocystis carinii Pneumonia
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