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Search / Trial NCT00002291

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

Launched by FISONS · Aug 30, 2001

Trial Information

Current as of March 23, 2025

Completed

Keywords

Aids Related Opportunistic Infections Pneumonia, Pneumocystis Carinii Pentamidine Dose Response Relationship, Drug Aerosols Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Fisons

Fisons is a distinguished pharmaceutical company dedicated to advancing healthcare through innovative research and development. With a strong focus on providing effective therapeutic solutions, Fisons specializes in a diverse range of medical fields, including respiratory, oncology, and infectious diseases. Committed to rigorous clinical trials and ethical standards, the company aims to bring safe and effective medications to market, improving patient outcomes and quality of life. Fisons leverages its extensive expertise and collaborative partnerships to drive scientific discovery and ensure compliance with regulatory requirements, positioning itself as a leader in the pharmaceutical industry.

Locations

Rochester, New York, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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