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
Completed · Not applicable
Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00002053
- 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). 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.
You may not qualify if…
- 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.
Where it is running
- Fisons Corp — Rochester, New York, United States
Full record on ClinicalTrials.gov
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