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A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

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). Patients must have: AIDS. Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP. Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted). Patients must be free of acute medical problems. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Asthma poorly controlled by medication. Receiving 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 at time of study entry. AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Unwilling to sign informed consent. Asthma poorly controlled by medication. Unwilling to cooperate with study procedures. Receiving active therapy for tuberculosis. Prior Medication: Excluded within 30 days of study entry: Antiretrovirals (other than zidovudine (AZT)). Immunomodulating agents. Corticosteroids. Prior Treatment: Excluded within 7 days of study entry: Transfusion. Patient cannot be transfusion dependent (requiring blood transfusion more than once per month). Active substance abuse.

Sites / Locations

  • Georgetown Univ
  • Veterans Administration Med Ctr
  • Northwestern Univ Med School
  • Beth Israel Deaconess - West Campus

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
NCT00002055
Brief Title
A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP
Official Title
A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP
Study Type
Interventional

2. Study Status

Record Verification Date
January 1990
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 effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple 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, 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). Patients must have: AIDS. Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP. Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted). Patients must be free of acute medical problems. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Asthma poorly controlled by medication. Receiving 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 at time of study entry. AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis. Pulmonary Kaposi's sarcoma. Unwilling to sign informed consent. Asthma poorly controlled by medication. Unwilling to cooperate with study procedures. Receiving active therapy for tuberculosis. Prior Medication: Excluded within 30 days of study entry: Antiretrovirals (other than zidovudine (AZT)). Immunomodulating agents. Corticosteroids. Prior Treatment: Excluded within 7 days of study entry: Transfusion. Patient cannot be transfusion dependent (requiring blood transfusion more than once per month). Active substance abuse.
Facility Information:
Facility Name
Georgetown Univ
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Veterans Administration Med Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20422
Country
United States
Facility Name
Northwestern Univ Med School
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Beth Israel Deaconess - West Campus
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Lavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)
Results Reference
background
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.
Results Reference
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A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

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