A Double-Blind Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP
This study has been completed.
Sponsor:
Fisons
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002053
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: October 1989
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Purpose
To evaluate and compare the safety, tolerability, and efficacy of biweekly administration of aerosol pentamidine versus placebo when used as a prophylactic agent in patients who have recovered from their first episode 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 Placebo-Controlled Group Comparative Study To Evaluate the Safety and Effectiveness of Aerosol Pentamidine in the Prophylaxis of Pneumocystis Carinii Pneumonia in Patients With AIDS Post First Episode PCP |
Resource links provided by NLM:
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). If AZT is started during the study, patients must have received = or > 15 days of aerosol pentamidine before beginning AZT.
Prior Medication:
Allowed:
- Zidovudine (AZT). If AZT began prior to study entry, patients must have received = or > 15 days of AZT before beginning aerosol pentamidine.
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
- Toxoplasmosis.
- Cryptococcosis.
- Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
- Pulmonary Kaposi's sarcoma (KS).
- Uncontrolled asthma.
- Active therapy for tuberculosis.
Patients with the following are excluded:
- Requiring ongoing active therapy for an opportunistic infection (O.I.) at time of entry or those with either of the following AIDS-defining O.I.'s prior to entry:
- Toxoplasmosis.
- Cryptococcosis.
- Transfusion dependent (requiring blood transfusion more than once per month). The last transfusion cannot have been given within 7 days of study entry.
- Pulmonary Kaposi's sarcoma (KS).
- Uncontrolled asthma.
Prior Medication:
Excluded within 30 days of study entry:
- Antiretroviral agents other than zidovudine (AZT).
- Immunomodulating agents.
- Corticosteroids.
Active therapy for tuberculosis.
Patients must:
- Have AIDS and recovered from their first episode of Pneumocystis carinii pneumonia (PCP).
- Be at least 2 weeks and no more than 24 weeks status post therapy for acute PCP.
- Have positive antibody to HIV by a Government-approved ELISA test kit, or confirmed Western blot test.
- Adequate pulmonary function (vital capacity = or > 80 percent of predicted; forced expiratory volume (FEV), 1 s = or > 65 percent of total FEV; and corrected pulmonary diffusion capacity > 60 percent of predicted).
- Free of acute medical problems.
Active substance abuse.
Contacts and Locations
More Information
Publications:
Keywords provided by NIH AIDS Clinical Trials Information Service:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 14, 2013
Publications:
Montaner JS, et al. Aerosolized pentamidine for the secondary prophylaxis of Pneumocystis carinii pneumonia in the acquired immunodeficiency syndrome: a report from the Canadian cooperative trial. Int Conf AIDS. 1989 Jun 4-9;5:295 (abstract no TBP54)
ClinicalTrials.gov Identifier: | NCT00002053 History of Changes |
Other Study ID Numbers: | 022B, 87-72 |
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 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