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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 - Article


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Sulfamethoxazole and Trimethoprim

Bactrim; Bactrim DS; Bethaprim; Co-trimoxazole; Cotrim; Cotrim DS; Septra; Septra DS; Sulfatrim 




Clinical Trial: 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

This study has been completed.

Sponsored by: Glaxo Wellcome
Information provided by: AIDS Clinical Trials Information Service

Purpose

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.

Condition Treatment or Intervention
Pneumonia, Pneumocystis carinii
HIV Infections
 Drug: Atovaquone

MedlinePlus related topics:  AIDS;   Fungal Infections;   Pneumocystis Carinii Infections;   Pneumonia;   Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Open Label

Eligibility

Genders Eligible for Study:  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.

Location Information


North Carolina
      Glaxo Wellcome Inc, Research Triangle Park,  North Carolina,  27709,  United States

More Information

Study ID Numbers:  053D; 33384-10
Record last reviewed:  April 1993
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00001990
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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Page Updated: October 3, 2005
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