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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002291
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1989
  Purpose

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).


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

Study Type: Interventional
Study Design: Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


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

  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).

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002291

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

Publications:
ClinicalTrials.gov Identifier: NCT00002291     History of Changes
Other Study ID Numbers: 022A, 87-71
Study First Received: November 2, 1999
Last Updated: June 23, 2005
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

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

ClinicalTrials.gov processed this record on October 22, 2014