A Study of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00001003
First received: November 2, 1999
Last updated: March 28, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Pneumonia, Pneumocystis Carinii
HIV Infections
Drug: Pentamidine isethionate
Drug: Zidovudine

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 20
Study Completion Date: January 1992
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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001003

Locations
United States, New York
SUNY - Stony Brook
Stony Brook, New York, United States, 11794
Sponsors and Collaborators
Investigators
Study Chair: GC Smaldone
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00001003     History of Changes
Other Study ID Numbers: ACTG 079, 11054
Study First Received: November 2, 1999
Last Updated: March 28, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections
Pneumonia, Pneumocystis carinii
Pentamidine
Nebulizers and Vaporizers
Lung
Administration, Inhalation
Acquired Immunodeficiency Syndrome
Zidovudine

Additional relevant MeSH terms:
Infection
HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Zidovudine
Pentamidine
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on September 18, 2014