Rochester,
New York
14603
Purpose:
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).
Criteria:
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.