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An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pentamidine isethionate
Sponsored by
Fisons
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Aerosols, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study. Concurrent Treatment: Allowed: Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study. Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP). Patients must be free of acute medical problems. Prior Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Requiring ongoing active therapy for an opportunistic infection at the time of study entry. Toxoplasmosis. Cryptococcus. Pulmonary Kaposi's sarcoma (KS). Asthma poorly controlled by medication. Concurrent Medication: Excluded: Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.: Septra, Fansidar, Dapsone, or eflornithine). Concurrent Treatment: Excluded: Transfusion dependency defined as > 1 blood transfusion per month. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry. Pulmonary Kaposi's sarcoma (KS). Active substance abuse by patients who cannot comply with study procedures. Unwilling to sign informed consent. In the opinion of the investigator cannot cooperate with study procedure. Asthma poorly controlled by medication. Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.: Septra, Fansidar, Dapsone, or eflornithine). Prior Medication: Excluded within 30 days of study entry: Antiretroviral agents, excluding zidovudine (AZT). Immunomodulating agents. Corticosteroids. Prior Treatment: Excluded within 7 days of study entry: Blood transfusion. Excluded: Requiring ongoing active treatments for an opportunistic infection at time of study entry. Active substance abuse by patients who cannot comply with study procedures.

Sites / Locations

  • Fisons Corp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Fisons
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1. Study Identification

Unique Protocol Identification Number
NCT00002030
Brief Title
An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
Official Title
An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 1989
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Fisons

4. Oversight

5. Study Description

Brief Summary
To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Pneumocystis Carinii, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Pneumonia, Pneumocystis carinii, Pentamidine, Aerosols, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Pentamidine isethionate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Concurrent Medication: Allowed: Zidovudine (AZT). Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study. Concurrent Treatment: Allowed: Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study. Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP). Patients must be free of acute medical problems. Prior Medication: Allowed: Zidovudine (AZT). Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Requiring ongoing active therapy for an opportunistic infection at the time of study entry. Toxoplasmosis. Cryptococcus. Pulmonary Kaposi's sarcoma (KS). Asthma poorly controlled by medication. Concurrent Medication: Excluded: Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.: Septra, Fansidar, Dapsone, or eflornithine). Concurrent Treatment: Excluded: Transfusion dependency defined as > 1 blood transfusion per month. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry. Pulmonary Kaposi's sarcoma (KS). Active substance abuse by patients who cannot comply with study procedures. Unwilling to sign informed consent. In the opinion of the investigator cannot cooperate with study procedure. Asthma poorly controlled by medication. Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.: Septra, Fansidar, Dapsone, or eflornithine). Prior Medication: Excluded within 30 days of study entry: Antiretroviral agents, excluding zidovudine (AZT). Immunomodulating agents. Corticosteroids. Prior Treatment: Excluded within 7 days of study entry: Blood transfusion. Excluded: Requiring ongoing active treatments for an opportunistic infection at time of study entry. Active substance abuse by patients who cannot comply with study procedures.
Facility Information:
Facility Name
Fisons Corp
City
Rochester
State/Province
New York
ZIP/Postal Code
14603
Country
United States

12. IPD Sharing Statement

Learn more about this trial

An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

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