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

This study has been completed.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	Glaxo Wellcome
Information provided by:	NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:	NCT00001990

Purpose

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.

Condition	Intervention
Pneumonia, Pneumocystis Carinii HIV Infections	Drug: Atovaquone

Study Type:	Interventional
Study Design:	Treatment, Open Label
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

Resource links provided by NLM:

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Atovaquone Pentamidine Pentamidine isetionate Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination

U.S. FDA Resources

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001990

Locations

United States, North Carolina
Glaxo Wellcome Inc
Research Triangle Park, North Carolina, United States, 27709

Sponsors and Collaborators

Glaxo Wellcome

More Information

No publications provided

Study ID Numbers:	053D, 33384-10
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001990 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:

Trimethoprim-Sulfamethoxazole Combination
Pneumonia, Pneumocystis carinii
Pentamidine

Antifungal Agents
Acquired Immunodeficiency Syndrome
atovaquone

Additional relevant MeSH terms:

Trypanocidal Agents
Anti-Infective Agents
Antiprotozoal Agents
Sexually Transmitted Diseases, Viral
Trimethoprim
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Trimethoprim-Sulfamethoxazole Combination
Renal Agents
Infection
Antimalarials
Pneumonia, Pneumocystis
Mycoses
Antiparasitic Agents
Respiratory Tract Diseases

Respiratory Tract Infections
Therapeutic Uses
Antifungal Agents
Pentamidine
Retroviridae Infections
Lung Diseases, Fungal
RNA Virus Infections
Immune System Diseases
Sulfamethoxazole
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Anti-Infective Agents, Urinary
Folic Acid Antagonists
Pharmacologic Actions
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on February 08, 2010