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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Pneumonia, Pneumocystis Carinii HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Atovaquone

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Glaxo Wellcome Inc

Research Triangle Park, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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33384-10

Identifier Type: -

Identifier Source: secondary_id

053D