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
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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 |
![](https://webarchive.library.unt.edu/web/20130315205831im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT).
- Standard or experimental treatments for an opportunistic infection or neoplasm (including aerosolized or intravenous pentamidine) that develops during the study.
Concurrent Treatment:
Allowed:
- Any standard or experimental treatment for an opportunistic infection or neoplasm that develops during the study.
Patients must have AIDS with at least one cytologically or histologically proven episode of Pneumocystis carinii pneumonia (PCP).
- Patients must be free of acute medical problems.
Prior Medication:
Allowed:
- Zidovudine (AZT).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Requiring ongoing active therapy for an opportunistic infection at the time of study entry.
- Toxoplasmosis.
- Cryptococcus.
- Pulmonary Kaposi's sarcoma (KS).
- Asthma poorly controlled by medication.
Concurrent Medication:
Excluded:
- Pentamidine by any route other than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- Septra, Fansidar, Dapsone, or eflornithine).
Concurrent Treatment:
Excluded:
- Transfusion dependency defined as > 1 blood transfusion per month.
Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at the time of entry or having either Toxoplasmosis or cryptococcosis at entry.
- Pulmonary Kaposi's sarcoma (KS).
- Active substance abuse by patients who cannot comply with study procedures.
- Unwilling to sign informed consent.
- In the opinion of the investigator cannot cooperate with study procedure.
- Asthma poorly controlled by medication.
- Patients may not receive pentamidine by any other route than aerosolized or intravenous or any other experimental agent for chemoprophylaxis of PCP while on the study (e.g.:
- Septra, Fansidar, Dapsone, or eflornithine).
Prior Medication:
Excluded within 30 days of study entry:
- Antiretroviral agents, excluding zidovudine (AZT).
- Immunomodulating agents.
- Corticosteroids.
Prior Treatment:
Excluded within 7 days of study entry:
- Blood transfusion.
- Excluded:
- Requiring ongoing active treatments for an opportunistic infection at time of study entry.
Active substance abuse by patients who cannot comply with study procedures.
![](https://webarchive.library.unt.edu/web/20130315205831im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20130315205831im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
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 |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Pneumonia, Pneumocystis carinii Pentamidine Aerosols Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
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 |
ClinicalTrials.gov processed this record on March 14, 2013