The Safety and Effectiveness of Pentamidine in the Prevention of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS Who Have Had PCP Before

Sponsor

Fisons (Industry)

Overall Status

Completed

CT.gov ID

NCT00002291

Collaborator

(none)

Location

Study Details

Study Description

Brief Summary

To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of 1 of 3 doses of aerosol pentamidine when used as a prophylactic agent in patients who have recovered from their first episode 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 Safety and Effectiveness of Three Different Doses of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode 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).

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).
Asthma requiring medication.
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 (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).
Unwilling to sign informed consent.
Cannot cooperate with study procedures.
Asthma requiring medication.

Prior Medication:

Excluded within 30 days of study entry:

Antiretrovirals other than zidovudine (AZT).
Immunomodulating agents.
Corticosteroids.

Patients must:

Have AIDS and recovered from their first episode of cytologically or histologically proven 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 any federally licensed ELISA test kit, or confirmed Western blot test.
Have 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.