A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Completion Date

1992-01-31

Brief Summary

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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

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 Blood is withdrawn to measure the blood level of PEN as done in ACTG 021 and ACTG 081.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

Conditions

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Pneumonia, Pneumocystis Carinii HIV Infections

Keywords

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AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Nebulizers and Vaporizers Lung Administration, Inhalation Acquired Immunodeficiency Syndrome Zidovudine

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Pentamidine isethionate

Intervention Type DRUG

Zidovudine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Concurrent Treatment:

Allowed:

* Local radiation for Kaposi's sarcoma.

* 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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GC Smaldone

Role: STUDY_CHAIR

Locations

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SUNY - Stony Brook

Stony Brook, New York, United States

Site Status

Countries

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United States

References

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Smaldone GC, Fuhrer J, Steigbigel RT, McPeck M. Factors determining pulmonary deposition of aerosolized pentamidine in patients with human immunodeficiency virus infection. Am Rev Respir Dis. 1991 Apr;143(4 Pt 1):727-37. doi: 10.1164/ajrccm/143.4_Pt_1.727.

Reference Type BACKGROUND

PMID: 2008984 (View on PubMed)

Other Identifiers

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11054

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 079

Identifier Type: -

Identifier Source: org_study_id