ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

This study has been completed.
Study NCT00001003.   Last updated on July 11, 2008.   Information provided by National Institute of Allergy and Infectious Diseases (NIAID)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
Official Title  Aerosols in the Treatment of Pneumocystis Carinii Pneumonia: A Nested Study Quantitating the Delivery of Aerosolized Pentamidine for Prophylaxis of PCP in Protocols ACTG 021 and ACTG 081
Brief Summary

To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine (AZT) in persons with advanced HIV disease and T4 cell count < 200 cells/mm3. To establish the range of pentamidine (PEN) deposition in AIDS patients participating in ACTG 021 and ACTG 081. To identify factors (breathing pattern, pulmonary function) that may be important in affecting the actual dose delivered to a given patient.

The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.

Detailed Description

The specific system that is used to deliver PEN to the lungs may determine whether a therapeutically effective dose is attained in the lungs. Therefore, this study will establish the amount of PEN that is deposited in the lungs of patients enrolled in protocols ACTG 021 and ACTG 081, who are being treated with PEN administered from the Marquest Respirgard II nebulizer.

Approximately 4 weeks after patients in ACTG 021 and ACTG 081 have begun PEN aerosol therapy for the prevention of PCP, patients undergo the first radioactive aerosol study. The patient inhales a mist while sitting with his/her back against a gamma camera. The resulting picture outlines the lungs. This mist contains a single dose of PEN mixed with a small amount of radioactivity (99m-technetium ertechnetate). The gamma camera determines where the particles deposit in the lungs. The radioactivity exposure is equivalent to a typical xray of the ribs. This procedure takes about 45 minutes; 6 hours later another 30-minute gamma camera image is obtained. Blood is withdrawn to measure the blood level of PEN as done in ACTG 021 and ACTG 081. The entire procedure is repeated near the end of the prophylactic schedule (about 10-12 months after the start of aerosol PEN treatments).

Study Phase
Study Type  Interventional
Study Design  Treatment, Placebo Control, Pharmacokinetics Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Pneumonia, Pneumocystis Carinii
HIV Infections
Intervention  Drug: Pentamidine isethionate
Drug: Zidovudine
MEDLINE PMIDs 2008984
Links Click here for more information about Zidovudine This link exits the ClinicalTrials.gov site
Click here for more information about Pentamidine isethionate This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  20
Start Date 
Completion Date
Eligibility Criteria 

Inclusion Criteria

Concurrent Treatment:

Allowed:

  • Local radiation for Kaposi's sarcoma.

Patients who successfully completed a course of study therapy for acute Pneumocystis carinii pneumonia (PCP) and who met the inclusion criteria for Protocol ACTG 021 or ACTG 081 and were randomized to the aerosolized pentamidine arm.

  • Patients who are currently receiving aerosolized pentamidine as prophylactic therapy for PCP.

Exclusion Criteria

The following patients are excluded:

  • Those enrolled in ACTG 021 and randomized to the oral prophylaxis arm.
  • Those enrolled in ACTG 081 and randomized to the trimethoprim / sulfamethoxazole and dapsone arms.

Prior Treatment:

Excluded within 2 weeks of study entry:

  • Transfusions of blood or red blood cells.

Co-Existing Condition:

  • Significant adverse effects.

Active substance abuse.

Gender Both
Ages 12 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001003
Organization ID ACTG 079
Secondary IDs ††
Study Sponsor  National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ††
Investigators 
Study Chair:     GC Smaldone        
Information Provided By National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date February 1992
First Received Date  November 2, 1999
Last Updated Date July 11, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers