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

Sponsor

Fisons (Industry)

Overall Status

Completed

CT.gov ID

NCT00002053

Collaborator

(none)

Location

Study Details

Study Description

Brief 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).

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 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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.