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
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|ClinicalTrials.gov Identifier: NCT00000722|
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : March 29, 2012
|Condition or disease||Intervention/treatment||Phase|
|Pneumonia, Pneumocystis Carinii HIV Infections||Drug: Pentamidine isethionate||Not Applicable|
Aerosolized pentamidine was as effective as intravenous pentamidine in treating PCP in animals. More of the pentamidine reached the lungs and less was found in the liver and kidney after pentamidine was given by aerosol than after an intravenous injection. This suggests that the toxicity of pentamidine may be less if given by aerosol than if given by the intravenous route.
Patients will inhale one dose of radiolabeled aerosol containing pentamidine, and an image of the lung will be taken immediately and then 24 hours later to determine the amount of pentamidine reaching the various areas of the lung. Patients will then undergo a bronchoalveolar lavage (BAL) in order to recover the PCP organism from the lung and to corroborate the diagnosis of PCP. If PCP organisms are detected, patients will be randomly assigned to aerosolized or intravenous pentamidine and treated for 21 days. Patients taking pentamidine by aerosol will repeat the radiolabeled aerosol study on day 9. The BAL will be repeated at the end of therapy for all patients. If patients do not improve within 9 days, they will be switched to another therapy. After completion of therapy, patients will be given the option of prophylactic therapy, i.e., doses of medication to prevent reinfection, for PCP. All patients will be carefully assessed every 4 weeks for 6 months whether they begin prophylactic therapy or not. Zidovudine (AZT) may not be taken during the 21-day trial because of the increased risk of side effects, but it can be resumed when PCP therapy is completed.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Actual Study Completion Date :||June 1991|
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000722
|United States, New York|
|SUNY - Stony Brook|
|Stony Brook, New York, United States, 117948153|
|Study Chair:||Smaldone GC|