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An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002030
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: November 1989
  Purpose

To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).


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

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients

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).
  • Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.

Concurrent Treatment:

Allowed:

  • Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.

Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).

  • Patients must be free of acute medical problems.

Prior Medication:

Allowed:

  • Zidovudine (AZT).

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
  • Toxoplasmosis.
  • Cryptococcus.
  • Pulmonary Kaposi's sarcoma (KS).
  • Asthma poorly controlled by medication.

Concurrent Medication:

Excluded:

  • Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
  • Septra, Fansidar, Dapsone, or eflornithine).

Concurrent Treatment:

Excluded:

  • Transfusion dependency defined as > 1 blood transfusion per month.

Patients with the following are excluded:

  • Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry.
  • Pulmonary Kaposi's sarcoma (KS).
  • Active substance abuse by patients who cannot comply with study procedures.
  • Unwilling to sign informed consent.
  • In the opinion of the investigator cannot cooperate with study procedure.
  • Asthma poorly controlled by medication.
  • Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
  • Septra, Fansidar, Dapsone, or eflornithine).

Prior Medication:

Excluded within 30 days of study entry:

  • Antiretroviral agents, excluding zidovudine (AZT).
  • Immunomodulating agents.
  • Corticosteroids.

Prior Treatment:

Excluded within 7 days of study entry:

  • Blood transfusion.
  • Excluded:
  • Requiring ongoing active treatments for an opportunistic infection at time of study entry.

Active substance abuse by patients who cannot comply with study procedures.

  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: NCT00002030

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

No publications provided

ClinicalTrials.gov Identifier: NCT00002030     History of Changes
Other Study ID Numbers: 022E, 87-72B, 88-21
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
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
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae 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 November 19, 2014