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CompletedNCT00001990Updated Jun 24, 2005

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

An interventional study of Atovaquone in Pneumonia, Pneumocystis Carinii and HIV Infections, sponsored by Glaxo Wellcome. Completed at 1 site in United States. Open to participants aged 1 Day and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Glaxo Wellcome · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Ages
1 Day and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pneumonia, Pneumocystis Carinii
  • HIV Infections

Keywords

  • Trimethoprim-Sulfamethoxazole Combination
  • Pneumonia, Pneumocystis carinii
  • Pentamidine
  • Antifungal Agents
  • Acquired Immunodeficiency Syndrome
  • atovaquone
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

Browse Pneumonia studies →

Lead sponsor

Glaxo Wellcome is the lead sponsor of 72 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Masking
None (open label)

Interventions

  • DrugAtovaquone
06

Study locations

1 site
  • Glaxo Wellcome Inc
    Research Triangle Park, North Carolina 27709, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00001990
Lead sponsor
Glaxo Wellcome
First posted
Aug 31, 2001
Last update
Jun 24, 2005
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 1993. You cannot join it, but the record below documents what was studied.

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