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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001990
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 1993
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Sulfamethoxazole
Trimethoprim
Atovaquone
Pentamidine
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials

ClinicalTrials.gov processed this record on September 22, 2014