A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001991
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2003

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00001991 on ClinicalTrials.gov Archive Site
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A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

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.

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Interventional
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Masking: Open Label
Primary Purpose: Treatment
  • Pneumonia, Pneumocystis Carinii
  • HIV Infections
Drug: Atovaquone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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Inclusion Criteria

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.

Exclusion Criteria

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.

Both
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00001991
107A, 566-501
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Glaxo Wellcome
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NIH AIDS Clinical Trials Information Service
April 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP