A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
This study has been completed.
Information provided by:
NIH AIDS Clinical Trials Information Service
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2003
To facilitate provision of atovaquone (566C80) to patients who have mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / SMX ); to monitor serious adverse events attributable to 566C80.
Pneumonia, Pneumocystis Carinii
||Masking: Open Label
Primary Purpose: Treatment
||A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients must have the following:
- Clinical diagnosis of acute mild to moderate Pneumocystis carinii pneumonia.
- Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX.
- Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol.
Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00001991
|Glaxo Wellcome Inc
|Research Triangle Park, North Carolina, United States, 27709 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 2, 1999
||June 23, 2005
||United States: Food and Drug Administration
Keywords provided by NIH AIDS Clinical Trials Information Service:
Pneumonia, Pneumocystis carinii
Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015
Lung Diseases, Fungal
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Infective Agents, Urinary
Molecular Mechanisms of Pharmacological Action