A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Information source: NIH AIDS Clinical Trials Information Service
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pneumonia, Pneumocystis Carinii; HIV Infections
Intervention: Atovaquone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Glaxo Wellcome
Summary
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.
Clinical Details
Official title: A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Study design: Treatment, Open Label
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Glaxo Wellcome Inc, Research Triangle Park, North Carolina 27709, United States
Additional Information
Last updated: June 23, 2005
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