Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001003
Status:
COMPLETED
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate and compare 3 anti-pneumocystis regimens plus zidovudine AZT in persons with advanced HIV disease and T4 cell count 200 cellsmm3 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
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 hisher 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
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 hisher 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11054 | REGISTRY | DAIDS ES Registry Number | None |