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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00002055 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | 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 |
| Official Title ICMJE | 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 |
| Brief Summary | 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). |
| Detailed Description | |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Double-Blind |
| Condition ICMJE |
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| Intervention ICMJE | Drug: Pentamidine isethionate |
| Study Arms / Comparison Groups | |
| Publications * | Murphy RL, Lavelle JP, Allan JD, Gordin FM, Dupliss R, Boswell SL, Waskin HA, Davies SF, Graziano FM, Saag MS, et al. Aerosol pentamidine prophylaxis following Pneumocystis carinii pneumonia in AIDS patients: results of a blinded dose-comparison study using an ultrasonic nebulizer. Am J Med. 1991 Apr;90(4):418-26. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Allowed:
Patients must have:
Exclusion Criteria Co-existing Condition: Patients with the following are excluded:
Concurrent Medication: Excluded:
Patients with the following are excluded:
Prior Medication: Excluded within 30 days of study entry:
Prior Treatment: Excluded within 7 days of study entry:
Active substance abuse. |
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00002055 |
| Responsible Party | |
| Study ID Numbers ICMJE | 022D, 88-7 |
| Study Sponsor ICMJE | Fisons |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | NIH AIDS Clinical Trials Information Service |
| Verification Date | January 1990 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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