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
This study has been completed.
Sponsor:
Fisons
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002055
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: January 1990
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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).
| Condition | Intervention |
|---|---|
|
Pneumonia, Pneumocystis Carinii HIV Infections |
Drug: Pentamidine isethionate |
| Study Type: | Interventional |
| Study Design: | Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Pentamidine isethionate
U.S. FDA Resources
Further study details as provided by NIH AIDS Clinical Trials Information Service:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
Concurrent Medication:
Allowed:
- Zidovudine (AZT).
Patients must have:
- AIDS.
- Recovered from their most recent episode of Pneumocystis carinii pneumonia (PCP). Patients must be at least 2 weeks status post therapy for acute PCP.
- Adequate pulmonary function (vital capacity = or > 65 percent of predicted; forced expiratory volume, 1 s = or > 55 percent of total FEV; and corrected pulmonary diffusion capacity > 50 percent of predicted).
- Patients must be free of acute medical problems.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- AIDS-defining opportunistic infection prior to entry such as toxoplasmosis and cryptococcosis.
- Pulmonary Kaposi's sarcoma.
- Asthma poorly controlled by medication.
- Receiving active therapy for tuberculosis.
Concurrent Medication:
Excluded:
- Active therapy for tuberculosis.
Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection at time of study entry.
- AIDS-defining opportunistic infection prior to study entry such as toxoplasmosis and cryptococcosis.
- Pulmonary Kaposi's sarcoma.
- Unwilling to sign informed consent.
- Asthma poorly controlled by medication.
- Unwilling to cooperate with study procedures.
- Receiving active therapy for tuberculosis.
Prior Medication:
Excluded within 30 days of study entry:
- Antiretrovirals (other than zidovudine (AZT)).
- Immunomodulating agents.
- Corticosteroids.
Prior Treatment:
Excluded within 7 days of study entry:
- Transfusion.
- Patient cannot be transfusion dependent (requiring blood transfusion more than once per month).
Active substance abuse.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002055
Locations
| United States, District of Columbia | |
| Veterans Administration Med Ctr | |
| Washington, District of Columbia, United States, 20422 | |
| Georgetown Univ | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Illinois | |
| Northwestern Univ Med School | |
| Chicago, Illinois, United States, 60611 | |
| United States, Massachusetts | |
| Beth Israel Deaconess - West Campus | |
| Boston, Massachusetts, United States, 02215 | |
Sponsors and Collaborators
Fisons
More Information
Publications:
Lavelle J, Murphy R, Harding P, Pierce P. Aerosolized pentamidine prophylaxis following Pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1990 Jun 20-23;6(2):374 (abstract no 2083)
| ClinicalTrials.gov Identifier: | NCT00002055 History of Changes |
| Other Study ID Numbers: | 022D, 88-7 |
| 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 |
Dose-Response Relationship, Drug 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 May 23, 2013