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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Atovaquone

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone

Eligibility Criteria

1 Day - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00001990

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Glaxo Wellcome

1. Study Identification

Unique Protocol Identification Number

NCT00001990

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

April 1993

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Glaxo Wellcome

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia, Pneumocystis Carinii, HIV Infections

Keywords

Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, Pentamidine, Antifungal Agents, Acquired Immunodeficiency Syndrome, atovaquone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Atovaquone

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Day

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Glaxo Wellcome Inc

City

Research Triangle Park

State/Province

North Carolina

ZIP/Postal Code

27709

Country

United States

Pneumonia, Pneumocystis Carinii, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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