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
Completed · Not applicable
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00002055
- Run by
- Fisons
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Georgetown Univ — Washington D.C., District of Columbia, United States
- Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
- Northwestern Univ Med School — Chicago, Illinois, United States
- Beth Israel Deaconess - West Campus — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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