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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002053
• Other study ID #: 022B
• Secondary ID: 87-72
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: October 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Pneumonia
• Pneumonia, Pneumocystis
• Pneumonia, Pneumocystis Carinii

Intervention

Drug:
• Pentamidine isethionate

Locations

Country	Name	City	State
United States	Fisons Corp	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Fisons

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)