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.

Sponsored by:	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

MedlinePlus related topics: AIDS Pneumonia

Drug Information available for: Sulfamethoxazole Trimethoprim Trimethoprim-sulfamethoxazole combination Atovaquone Clotrimazole Miconazole Miconazole nitrate Tioconazole Pentamidine

U.S. FDA Resources

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

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

Study ID Numbers:	053D, 33384-10
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00001990
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

Study placed in the following topic categories:

Trimethoprim
Sexually Transmitted Diseases, Viral
Sulfamethoxazole
Clotrimazole
Miconazole
Acquired Immunodeficiency Syndrome
Tioconazole
Trimethoprim-Sulfamethoxazole Combination
Immunologic Deficiency Syndromes
Folic Acid
Virus Diseases
Mycoses

Pneumonia, Pneumocystis
Atovaquone
Pneumocystis Infections
Respiratory Tract Diseases
Respiratory Tract Infections
HIV Infections
Lung Diseases
Sexually Transmitted Diseases
Pentamidine
Retroviridae Infections
Pneumonia
Lung Diseases, Fungal

Additional relevant MeSH terms:

Anti-Infective Agents
Trypanocidal Agents
RNA Virus Infections
Antiprotozoal Agents
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Anti-Infective Agents, Urinary

Folic Acid Antagonists
Renal Agents
Infection
Pharmacologic Actions
Antimalarials
Antiparasitic Agents
Antifungal Agents
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 15, 2009