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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Pneumonia, Pneumocystis Carinii
HIV Infections

Treatments

Drug: Atovaquone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00001990
33384-10
053D

Details and patient eligibility

About

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.

Sex

All

Ages

1+ day old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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