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Sponsored by: |
Fisons |
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Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00002030 |
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 |
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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 |
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.
Study ID Numbers: | 022E, 87-72B, 88-21 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00002030 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Aerosols Acquired Immunodeficiency Syndrome |
Opportunistic Infections Sexually Transmitted Diseases, Viral Clotrimazole Pneumocystosis Miconazole Acquired Immunodeficiency Syndrome Tioconazole Immunologic Deficiency Syndromes Virus Diseases Mycoses Pneumonia, Pneumocystis |
Pneumocystis Infections Respiratory Tract Infections Respiratory Tract Diseases HIV Infections Lung Diseases AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Pentamidine Retroviridae Infections Pneumonia Lung Diseases, Fungal |
Trypanocidal Agents Anti-Infective Agents Antiparasitic Agents Antiprotozoal Agents RNA Virus Infections Slow Virus Diseases |
Immune System Diseases Therapeutic Uses Antifungal Agents Lentivirus Infections Infection Pharmacologic Actions |