An Open-Label, Uncontrolled Clinical Trial of Oral 566C80 for the Treatment of Patients With Severe PCP Who Are Intolerant and/or Unresponsive to Therapy With Trimethoprim/Sulfamethoxazole and Parenteral Pentamidine

Completed · Not applicable

Conditions studied: Pneumonia, Pneumocystis Carinii, HIV Infections

In brief

To facilitate provision of atovaquone (566C80) to patients who have severe Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.

Key facts

Study ID

NCT00001990

Run by

Glaxo Wellcome

Last updated by the study team

2005-06-24

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have the following:
• Clinical diagnosis of acute severe Pneumocystis carinii pneumonia (PCP).
• Dose-limiting intolerance to TMP / SMX and parenteral pentamidine.
• Willingness and ability to give informed consent.

You may not qualify if…

• Co-existing Condition:
• Excluded:
• Patients with a history of intolerance to 566C80. Patients with the following prior conditions are excluded: History of serious dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.
• Required:
• Trimethoprim / sulfamethoxazole (TMP/SMX); pentamidine.

Where it is running

• Glaxo Wellcome Inc — Research Triangle Park, North Carolina, United States

Full record on ClinicalTrials.gov

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