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 on November 2, 1999. Last Updated on 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:	Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS Pneumonia

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

U.S. FDA Resources

Further study details as provided by NIH AIDS Clinical Trials Information Service:

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

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

HIV Infections
Acquired Immunodeficiency Syndrome
Pneumonia
Pneumonia, Pneumocystis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Lung Diseases
Respiratory Tract Diseases

Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Pentamidine
Trimethoprim
Trimethoprim-Sulfamethoxazole Combination
Atovaquone
Sulfamethoxazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on February 09, 2012