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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

This study has been completed.

Sponsored by: Fisons
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002055
  Purpose

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).


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

MedlinePlus related topics:   AIDS    Pneumonia   

Drug Information available for:   Pentamidine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind
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
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002055

Locations
United States, District of Columbia
Veterans Administration Med Ctr    
      Washington, District of Columbia, United States, 20422
Georgetown Univ    
      Washington, District of Columbia, United States, 20007
United States, Illinois
Northwestern Univ Med School    
      Chicago, Illinois, United States, 60611
United States, Massachusetts
Beth Israel Deaconess - West Campus    
      Boston, Massachusetts, United States, 02215

Sponsors and Collaborators
Fisons
  More Information


Publications:

Study ID Numbers:   022D, 88-7
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002055
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections  
Pneumonia, Pneumocystis carinii  
Pentamidine  
Dose-Response Relationship, Drug
Aerosols
Acquired Immunodeficiency Syndrome

Study placed in the following topic categories:
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Clotrimazole
Pneumocystosis
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Lung Diseases
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Pentamidine
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:
Trypanocidal Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Antifungal Agents
Lentivirus Infections
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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