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NCT00001990 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001990
Other study ID # 053D
Secondary ID 33384-10
Status Completed
Phase N/A
First received November 2, 1999
Last updated June 23, 2005

Study information
Verified date April 1993
Source NIH AIDS Clinical Trials Information Service
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Atovaquone

Locations
Country Name City State
United States Glaxo Wellcome Inc Research Triangle Park North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Glaxo Wellcome

Country where clinical trial is conducted

United States, 

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