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The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before

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, Dose-Response Relationship, Drug, 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). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: Toxoplasmosis. Cryptococcosis. Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. Pulmonary Kaposi's sarcoma (KS). Asthma requiring medication. Active therapy for tuberculosis. Concurrent Medication: Excluded: Active therapy for tuberculosis. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: Toxoplasmosis. Cryptococcosis. Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. Pulmonary Kaposi's sarcoma (KS). Unwilling to sign informed consent. Cannot cooperate with study procedures. Asthma requiring medication. Prior Medication: Excluded within 30 days of study entry: Antiretrovirals other than zidovudine (AZT). Immunomodulating agents. Corticosteroids. Patients must: Have AIDS and recovered from their first episode of cytologically or histologically proven Pneumocystis carinii pneumonia (PCP). Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP. Have positive antibody to HIV by any federally licensed ELISA test kit, or confirmed Western blot test. Have adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted). Free of acute medical problems. Active substance abuse.

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
NCT00002291
Brief Title
The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before
Official Title
A Double-Blind Group Comparative Study To Evaluate the Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP
Study Type
Interventional

2. Study Status

Record Verification Date
October 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 and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have recovered from their first episode 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, Dose-Response Relationship, Drug, Aerosols, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Double

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). Exclusion Criteria Co-existing Condition: Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: Toxoplasmosis. Cryptococcosis. Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. Pulmonary Kaposi's sarcoma (KS). Asthma requiring medication. Active therapy for tuberculosis. Concurrent Medication: Excluded: Active therapy for tuberculosis. Patients with the following are excluded: Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry: Toxoplasmosis. Cryptococcosis. Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry. Pulmonary Kaposi's sarcoma (KS). Unwilling to sign informed consent. Cannot cooperate with study procedures. Asthma requiring medication. Prior Medication: Excluded within 30 days of study entry: Antiretrovirals other than zidovudine (AZT). Immunomodulating agents. Corticosteroids. Patients must: Have AIDS and recovered from their first episode of cytologically or histologically proven Pneumocystis carinii pneumonia (PCP). Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP. Have positive antibody to HIV by any federally licensed ELISA test kit, or confirmed Western blot test. Have adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted). Free of acute medical problems. Active substance abuse.
Facility Information:
Facility Name
Fisons Corp
City
Rochester
State/Province
New York
ZIP/Postal Code
14603
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2012082
Citation
Murphy RL, Lavelle JP, Allan JD, Gordin FM, Dupliss R, Boswell SL, Waskin HA, Davies SF, Graziano FM, Saag MS, et al. Aerosol pentamidine prophylaxis following Pneumocystis carinii pneumonia in AIDS patients: results of a blinded dose-comparison study using an ultrasonic nebulizer. Am J Med. 1991 Apr;90(4):418-26.
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The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before

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