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A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00001991
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: April 2003
  Purpose

To facilitate provision of atovaquone (566C80) to patients who have mild to moderate Pneumocystis carinii pneumonia (PCP) and are intolerant and/or unresponsive to trimethoprim / sulfamethoxazole (TMP / 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: A Treatment IND for 566C80 Therapy of Pneumocystis Carinii Pneumonia

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 mild to moderate Pneumocystis carinii pneumonia.
  • Dose-limiting intolerance to TMP / SMX or inadequate response to TMP / SMX.
  • Willingness and ability to give informed consent. The clinical condition of the patient and appropriate physiologic criteria should be used in evaluating patients for therapy with 566C80. Patients who are rapidly progressing in disease severity or have severe disease as evidenced by sustained tachypnea (e.g., sustained respiratory rate > 30 breaths/minute), rapid deterioration in (A-a)DO2 and chest radiograph may not be appropriate candidates for oral therapy, including 566C80. Therapy with parenteral pentamidine should be undertaken in these cases. Treatment with IV trimetrexate or primaquine / clindamycin should be considered for these patients unless the patient is known to have dose-limiting intolerance to these agents. Patients with severe PCP who are intolerant and/or unresponsive to therapy with TMP / SMX and parenteral pentamidine may enroll in the 566C80 open-label compassionate plea protocol.

Exclusion Criteria

Patients with the following prior conditions are excluded: History of serious or dose-limiting adverse experience during previous 566C80 therapy, thought to be attributable to the drug.

  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: NCT00001991

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: NCT00001991     History of Changes
Other Study ID Numbers: 107A, 566-501
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
Antifungal Agents
Acquired Immunodeficiency Syndrome
atovaquone

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Pneumonia
Pneumonia, Pneumocystis
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lung Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
RNA Virus Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Atovaquone
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents

ClinicalTrials.gov processed this record on November 25, 2014