A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

Not Applicable

Completed

• Conditions: HIV Infections; Pneumonia, Pneumocystis Carinii

• Registration Number: NCT00001003
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 Blood is withdrawn to measure the blood level of PEN as done in ACTG 021 and ACTG 081.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 Timeline

• Study Completion: 1992-01
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

SUNY - Stony Brook; 🇺🇸 Stony Brook, New York, United States