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

Sponsor

Fisons (Industry)

Overall Status

Completed

CT.gov ID

NCT00002055

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Pentamidine isethionate	N/A

Study Design

Study Type:

Interventional

Masking:

Double

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgetown Univ	Washington	District of Columbia	United States	20007
2	Veterans Administration Med Ctr	Washington	District of Columbia	United States	20422
3	Northwestern Univ Med School	Chicago	Illinois	United States	60611
4	Beth Israel Deaconess - West Campus	Boston	Massachusetts	United States	02215