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
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
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 severe Pneumocystis
carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim /
sulfamethoxazole ( TMX / SMX ); to monitor serious adverse events attributable to 566C80.
Clinical Details
Official title: 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
Study design: Masking: Open Label, Primary Purpose: Treatment
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
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.
Exclusion Criteria
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.
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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