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

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002030 on ClinicalTrials.gov Archive Site
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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
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

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).

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Interventional
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Masking: Open Label
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Pentamidine isethionate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002030
022E, 87-72B, 88-21
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Fisons
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NIH AIDS Clinical Trials Information Service
November 1989

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP