An Open Label Study to Evaluate the Long-Term Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in AIDS Patients
Completed · Not applicable
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
To evaluate the safety, tolerability, and efficacy of long term, bi-weekly administration of aerosol pentamidine when used as a prophylactic agent in patients who have had at least two or more episodes of AIDS-associated Pneumocystis carinii pneumonia (PCP).
Key facts
- Study ID
- NCT00002030
- 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).
- Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.
- Concurrent Treatment:
- Allowed:
- Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.
- Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
- Patients must be free of acute medical problems.
- Prior Medication:
- Allowed:
- Zidovudine (AZT).
You may not qualify if…
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
- Toxoplasmosis.
- Cryptococcus.
- Pulmonary Kaposi's sarcoma (KS).
- Asthma poorly controlled by medication.
- Concurrent Medication:
- Excluded:
- Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- Septra, Fansidar, Dapsone, or eflornithine).
- Concurrent Treatment:
- Excluded:
- Transfusion dependency defined as > 1 blood transfusion per month.
- Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry.
- Pulmonary Kaposi's sarcoma (KS).
- Active substance abuse by patients who cannot comply with study procedures.
- Unwilling to sign informed consent.
- In the opinion of the investigator cannot cooperate with study procedure.
- Asthma poorly controlled by medication.
- Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- Septra, Fansidar, Dapsone, or eflornithine).
- Prior Medication:
- Excluded within 30 days of study entry:
Where it is running
- Fisons Corp — Rochester, New York, United States
Full record on ClinicalTrials.gov
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