NCT00001991

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2003

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Pneumonia, Pneumocystis CariniiHIV Infections

Keywords

Trimethoprim-Sulfamethoxazole CombinationPneumonia, Pneumocystis cariniiAntifungal AgentsAcquired Immunodeficiency Syndromeatovaquone

Interventions

AtovaquoneDRUG

Eligibility Criteria

Age1 Day+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glaxo Wellcome Inc

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Pneumonia, PneumocystisHIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Atovaquone

Condition Hierarchy (Ancestors)

Lung Diseases, FungalMycosesBacterial Infections and MycosesInfectionsPneumocystis InfectionsRespiratory Tract InfectionsPneumoniaLung DiseasesRespiratory Tract DiseasesBlood-Borne InfectionsCommunicable DiseasesSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

NaphthoquinonesQuinonesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2003-04

Locations

US(1)