Factors determining pulmonary deposition of aerosolized pentamidine in patients with human immunodeficiency virus infection.
G C Smaldone, J Fuhrer, R T Steigbigel...
https://pubmed.ncbi.nlm.nih.gov/2008984Completed
Phase Not Applicable
Age: 12Years +
All Genders
ID00001003
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
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
Who Can Participate
Age: 12Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
SUNY - Stony Brook
Stony Brook, New York, United States, 11794
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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