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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 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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001990
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia, Pneumocystis Carinii, HIV Infections

Keywords

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

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.

Interventions

DRUGAtovaquone

Sponsors

Glaxo Wellcome
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Days to No maximum
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

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026