search
Back to results

A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

Primary Purpose

Pneumonia, Pneumocystis Carinii, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atovaquone
Sponsored by
Glaxo Wellcome
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumonia, Pneumocystis Carinii focused on measuring Trimethoprim-Sulfamethoxazole Combination, Pneumonia, Pneumocystis carinii, 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 mild to moderate Pneumocystis carinii pneumonia. Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX. Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol. Exclusion Criteria Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

Sites / Locations

  • Glaxo Wellcome Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Glaxo Wellcome
search

1. Study Identification

Unique Protocol Identification Number
NCT00001991
Brief Title
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Official Title
A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

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 mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / 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, 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 mild to moderate Pneumocystis carinii pneumonia. Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX. Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol. Exclusion Criteria Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.
Facility Information:
Facility Name
Glaxo Wellcome Inc
City
Research Triangle Park
State/Province
North Carolina
ZIP/Postal Code
27709
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

We'll reach out to this number within 24 hrs