Search / Trial NCT00001994

A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine

Launched by GLAXO WELLCOME · Aug 30, 2001

Trial Information

Current as of December 27, 2024

Completed

Keywords

Toxoplasmosis Aids Related Opportunistic Infections Naphthoquinones Encephalitis Acquired Immunodeficiency Syndrome

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Patients must have the following:
  • Presumptive diagnosis of AIDS.
  • Cerebral toxoplasmosis.
  • Expected survival of at least four weeks without therapy.
  • Willing and able to give informed consent.
  • Prior Medication:
  • Allowed:
  • Pyrimethamine-sulfonamide.
  • Clindamycin-sulfonamide.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Significant emotional disorder or psychosis.
  • Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
  • * Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
  • Ensure Plus) or pulverized form through a nasogastric tube.
  • Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
  • Concurrent Medication:
  • Excluded:
  • Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.
  • * First three weeks of treatment:
  • * Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:
  • ddI,ddC).
  • Patients with the following are excluded:
  • Significant emotional disorder or psychosis.
  • Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.
  • * Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:
  • Ensure Plus) or pulverized form through a nasogastric tube.
  • Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.
  • Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.

About Glaxo Wellcome

Glaxo Wellcome, a leading global biopharmaceutical company, is dedicated to advancing healthcare through innovative research and development of new therapies. With a strong focus on addressing unmet medical needs, Glaxo Wellcome combines scientific excellence with a commitment to improving patient outcomes across various therapeutic areas, including respiratory, infectious diseases, and oncology. The company is recognized for its robust clinical trial portfolio, leveraging cutting-edge technology and collaborative partnerships to drive the development of transformative treatments. Glaxo Wellcome upholds the highest ethical standards in clinical research, ensuring patient safety and integrity throughout the trial process.

Locations

Houston, Texas, United States

Los Angeles, California, United States

New York, New York, United States

San Francisco, California, United States

New York, New York, United States

Washington, District Of Columbia, United States

Oakland, California, United States

San Francisco, California, United States

New York, New York, United States

Durham, North Carolina, United States

Memphis, Tennessee, United States

Vancouver, British Columbia, Canada

Toronto, Ontario, Canada

San Francisco, California, United States

Annandale, Virginia, United States

Portland, Oregon, United States

Baltimore, Maryland, United States

Stony Brook, New York, United States

Calgary, Alberta, Canada

Atlanta, Georgia, United States

Houston, Texas, United States

Montreal, Quebec, Canada

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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