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| Sponsor: | Fisons |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002030 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Concurrent Treatment:
Allowed:
Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
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 by patients who cannot comply with study procedures.
Contacts and Locations
More Information
| Study ID Numbers: | 022E, 87-72B, 88-21 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002030 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Aerosols Acquired Immunodeficiency Syndrome |
|
Trypanocidal Agents Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Infection Pneumonia, Pneumocystis Mycoses Antiparasitic Agents Respiratory Tract Diseases Respiratory Tract Infections Antifungal Agents Therapeutic Uses Pentamidine |
Retroviridae Infections Lung Diseases, Fungal RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Pneumocystis Infections HIV Infections Lung Diseases Sexually Transmitted Diseases Lentivirus Infections Pneumonia |