- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001996
A Phase II Open Randomized Comparison of 566C80 and Pentamidine Isethionate for the Treatment of Pneumocystis Carinii Pneumonia in AIDS Patients Who Are Intolerant of Trimethoprim / Sulfamethoxazole
June 23, 2005 updated by: Glaxo Wellcome
To compare the safety of atovaquone (566C80) with intravenous (IV) pentamidine for the treatment of mild to moderate Pneumocystis carinii pneumonia (PCP) in AIDS patients who are intolerant of therapy with trimethoprim / sulfamethoxazole (TMP / SMX) by comparing the incidence of premature discontinuation of therapy due to toxicity.
To compare the efficacy of 566C80 with intravenous (IV) pentamidine for the treatment of mild to moderate PCP in the same population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Berkeley, California, United States, 94704
- East Bay AIDS Ctr
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Harbor City, California, United States, 90710
- Kaiser Foundation Hosp
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Los Angeles, California, United States, 90095
- UCLA CARE Ctr
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Los Angeles, California, United States, 90048
- Cedars Sinai Med Ctr
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Orange, California, United States, 92668
- UCI Med Ctr
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Redwood City, California, United States, 94063
- AIDS Community Research Consortium
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San Francisco, California, United States, 94114
- Davies Med Ctr
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San Ramone, California, United States, 94583
- Dr Patrick Joseph
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Georgia
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Atlanta, Georgia, United States, 30345
- Infectious Disease Research Consortium of Georgia
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston City Hosp
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Boston, Massachusetts, United States, 02114
- Massachusetts Gen Hosp
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New York
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New York, New York, United States, 10003
- Beth Israel Med Ctr
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New York, New York, United States, 10037
- Harlem AIDS Treatment Group / Harlem Hosp Ctr
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New York, New York, United States, 10011
- Saint Vincent's Hosp and Med Ctr
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Ohio
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Cincinnati, Ohio, United States, 452670405
- Univ of Cincinnati
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Oregon
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Portland, Oregon, United States, 97210
- Portland Veterans Adm Med Ctr / Rsch & Education Grp
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Buckley Braffman Stern Med Associates
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Tennessee
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Memphis, Tennessee, United States, 38103
- Regional Med Ctr at Memphis
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Houston, Texas, United States, 77004
- Gathe, Joseph, M.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria
Patients must have the following:
- History of, or are currently experiencing, intolerance to TMP / SMX, or to another sulfonamide, which required discontinuation of therapy.
- Pneumocystis carinii pneumonia (PCP).
- Willing and able to give informed consent.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded.
- Malabsorption disorder or vomiting that would, in the judgement of the investigator, potentially limit the retention and absorption of an oral therapy.
- Concurrent bacterial, fungal, or viral pneumonitis, pulmonary Kaposi's sarcoma, or other concurrent illness, or chronic pulmonary disease that, in the investigator's opinion, would make interpretation of drug efficacy difficult.
- Present occurrences of abnormal prolongation of QT interval on standard, 12 lead EKG.
Concurrent Medication:
Excluded:
- Drugs with potential anti-pneumocystis effect (eg:
- sulfonamides, dapsone, trimethoprim, other dihydrofolate reductase (DHFR) inhibitors, primaquine, clindamycin, sulfonylureas).
- Ganciclovir.
- Zidovudine.
- Investigational agents including anti-retroviral agents (ddI, ddC, etc.). Patients receiving these drugs prior to entry must discontinue their use during the therapy phase (21 days) of the trial.
- Corticosteroids (except replacement therapy) during the 21 day treatment period (Strata A and C Patients).
- Class 1A antiarrhythmics (ie:
- quinidine, procainamide, disopyramide).
Patients with the following are excluded:
- Judged by the investigator to be in impending respiratory failure.
- Known intolerance to parenteral pentamidine isethionate, or therapeutic failure with same for treatment of current episode of PCP.
- Significant psychosis or emotional disorder that, in the investigator's opinion, would preclude the patient from adhering to the protocol.
- Inability or unwillingness to take medication orally or with food.
- Prior documented glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History, or present occurrences, of abnormal prolongation of QT interval on standard, 12 lead EKG.
- Termination from FDA 053A due to toxicity.
- For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
Prior Medication:
Excluded:
- Treatment within 4 weeks of entry for a prior episode of PCP.
- For patients entering under historic intolerance criteria (Groups A and B), prior therapy for this episode of PCP is an exclusion.
Required:
- Adjuvant prednisone for patient enrolled in Strata B or D.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dohn M, Weinberg W, Rosenstock J, Follansbee S, Torres R, Caldwell P. Atovaquone vs. pentamidine for pneumocystis carinii pneumonia in patients with AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):372 (abstract no PO-B10-1421)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
August 30, 2001
First Posted (Estimate)
August 31, 2001
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
May 1, 1992
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections and Mycoses
- Mycoses
- Lung Diseases, Fungal
- Pneumocystis Infections
- Pneumonia
- Pneumonia, Pneumocystis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antifungal Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Trypanocidal Agents
- Atovaquone
- Pentamidine
Other Study ID Numbers
- 053B
- 05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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