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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fisons
• Treatments: Pentamidine

Criteria

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.