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A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002053
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
  Purpose
To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode of AIDS-associated Pneumocystis carinii pneumonia (PCP).

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

Study Type: Interventional
Study Design: Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

  • Zidovudine (AZT). If AZT is started during the study, patients must have received = or > 15 days of aerosol pentamidine before beginning AZT.

Prior Medication:

Allowed:

  • Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or > 15 days of AZT before beginning aerosol pentamidine.

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).
  • Uncontrolled asthma.
  • 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).
  • Uncontrolled asthma.

Prior Medication:

Excluded within 30 days of study entry:

  • Antiretroviral agents other than zidovudine (AZT).
  • Immunomodulating agents.
  • Corticosteroids.

Active therapy for tuberculosis.

Patients must:

  • Have AIDS and recovered from their first episode of 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 a Government-approved ELISA test kit, or confirmed Western blot test.
  • 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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002053


Locations
United States, New York
Fisons Corp
Rochester, New York, United States, 14603
Sponsors and Collaborators
Fisons
  More Information

Publications:
Montaner JS, et al. Aerosolized pentamidine for the secondary prophylaxis of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome: a report from the Canadian cooperative trial. Int Conf AIDS. 1989 Jun 4-9;5:295 (abstract no TBP54)

ClinicalTrials.gov Identifier: NCT00002053     History of Changes
Other Study ID Numbers: 022B
87-72
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
Last Verified: October 1989

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

Additional relevant MeSH terms:
HIV Infections
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pentamidine
Antifungal Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents


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