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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: | Masking: Open Label Primary Purpose: Treatment |
| 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
| ClinicalTrials.gov Identifier: | NCT00002030 History of Changes |
| Other Study ID Numbers: | 022E, 87-72B, 88-21 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Aerosols Acquired Immunodeficiency Syndrome |
|
HIV Infections Acquired Immunodeficiency Syndrome Pneumonia Pneumonia, Pneumocystis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Lung Diseases |
Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases, Fungal Mycoses Pneumocystis Infections Pentamidine Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antiprotozoal Agents Antiparasitic Agents Trypanocidal Agents |