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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
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

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

Resource links provided by NLM:

  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
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002055     History of Changes
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:
Anti-Infective Agents
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Pneumocystosis
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
Respiratory Tract Infections
Respiratory Tract Diseases
HIV Infections
Antifungal Agents
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
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Infection
Pneumonia, Pneumocystis
Mycoses
Antiparasitic Agents
Respiratory Tract Diseases
Respiratory Tract Infections
Antifungal Agents
Therapeutic Uses
Pentamidine
Retroviridae Infections
Lung Diseases, Fungal
RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Virus Diseases
Pneumocystis Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Lentivirus Infections
Pneumonia

ClinicalTrials.gov processed this record on September 02, 2009