A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

HIV Infections Clinical Trial

Official title:

A Double-Blind Group Comparative Study To Evaluate the Long-Term Safety and Effectiveness of Two Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients With Multiple Episodes of PCP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002055
• Other study ID #: 022D
• Secondary ID: 88-7
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: January 1990
• 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 effectiveness of long-term biweekly administration of 1 of 2 doses of aerosol pentamidine when used as a prophylactic agent in patients who have had multiple episodes 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).

Patients must have:

• AIDS.

• Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP.

• Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted).

• Patients must be free of acute medical problems.

Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

• AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis.

• Pulmonary Kaposi's sarcoma.

• Asthma poorly controlled by medication.

• Receiving 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 at time of study entry.

• AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis.

• Pulmonary Kaposi's sarcoma.

• Unwilling to sign informed consent.

• Asthma poorly controlled by medication.

• Unwilling to cooperate with study procedures.

• Receiving active therapy for tuberculosis.

Prior Medication:

Excluded within 30 days of study entry:

• Antiretrovirals (other than zidovudine (AZT)).

• Immunomodulating agents.

• Corticosteroids.

Prior Treatment:

Excluded within 7 days of study entry:

• Transfusion.

• Patient cannot be transfusion dependent (requiring blood transfusion more than once per month).

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	Beth Israel Deaconess - West Campus	Boston	Massachusetts
United States	Northwestern Univ Med School	Chicago	Illinois
United States	Georgetown Univ	Washington	District of Columbia
United States	Veterans Administration Med Ctr	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fisons

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)

Murphy RL, Lavelle JP, Allan JD, Gordin FM, Dupliss R, Boswell SL, Waskin HA, Davies SF, Graziano FM, Saag MS, et al. Aerosol pentamidine prophylaxis following Pneumocystis carinii pneumonia in AIDS patients: results of a blinded dose-comparison study using an ultrasonic nebulizer. Am J Med. 1991 Apr;90(4):418-26. — View Citation