Search / Trial NCT00000794

Phase II Randomized Open-Label Trial of Atovaquone Plus Pyrimethamine and Atovaquone Plus Sulfadiazine for the Treatment of Acute Toxoplasmic Encephalitis

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of June 14, 2024

Completed

Keywords

Pyrimethamine Leucovorin Drug Therapy, Combination Encephalitis Acquired Immunodeficiency Syndrome Antiprotozoal Agents Clarithromycin Atovaquone Toxoplasmosis, Cerebral Sulfadiazine

Description

AIDS patients with toxoplasmic encephalitis who receive the standard therapy combination of sulfadiazine and pyrimethamine experience a high frequency of severe toxicity. Atovaquone, an antibiotic that has demonstrated efficacy against toxoplasmosis in animal models and in preclinical testing has been well tolerated, is now available as a suspension, which is more readily absorbed than the tablet form of the drug. The efficacy and safety of atovaquone in combination with sulfadiazine or pyrimethamine will be studied. Seventy patients are randomized to receive atovaquone with either pyrimet...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for PCP prophylaxis.
  • PER AMENDMENT 4/3/96:
  • History of treatment limiting toxicity to pyrimethamine. Patients with a history of treatment limiting toxicity to both pyrimethamine and sulfonamides will be assigned to receive atovaquone plus clarithromycin.
  • Patients must have:
  • Documented HIV infection or diagnosis of AIDS (except for CD4 count < 200 cells/mm3).
  • Toxoplasmic encephalitis.
  • Ability to give informed consent or legal designee who could give consent.
  • PER AMENDMENT 4/3/96:
  • NOTE - A history of treatment limiting toxicity to both pyrimethamine and sulfonamides will result in the patient being enrolled in the atovaquone plus clarithromycin arm.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following symptoms or conditions are excluded:
  • Coma.
  • Opportunistic infection that requires either acute or maintenance treatment with disallowed medications.
  • Any infections or neoplasms of the central nervous system other than Toxoplasma, HIV encephalopathy, or syphilis.
  • Unable to take oral study drugs.
  • Malabsorption (i.e., three or more episodes of diarrhea per day that has caused >= 10 percent loss of body weight over the past 4 weeks).
  • Positive CSF or serum for Cryptococcus antigen or culture (a positive serum antigen only is acceptable, provided patient received prior antifungal therapy and is on maintenance, and the likelihood of recurrence is low).
  • Malignancy requiring use of cytotoxic chemotherapy.
  • Medical or social condition that would adversely affect study participation or compliance.
  • Concurrent Medication:
  • Excluded:
  • Trimethoprim-sulfamethoxazole.
  • Primaquine.
  • Sulfonamides.
  • Antifolates.
  • Dapsone.
  • Clarithromycin (except for patients in the cohort to receive this drug).
  • Azithromycin.
  • Clindamycin.
  • Other macrolides.
  • Gamma interferon.
  • Metoclopramide.
  • G-CSF or GM-CSF.
  • Excluded in patients receiving clarithromycin as study drug:
  • Terfenadine, astemizole, or any other long-acting, non-sedating antihistamines.
  • PER AMENDMENT 4/3/96:
  • Cisapride - may increase GI motility and may increase drug absorption.
  • Patients with the following prior conditions are excluded:
  • History of treatment-limiting toxicity to atovaquone.
  • Receipt of > 96 hours (per amendment) of treatment prior to study entry for the current episode of toxoplasmic encephalitis.

Attachments

readout_NCT00000794_2024-06-14.pdf

4.5 MB

NCT00000794_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

Miami, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Indianapolis, Indiana, United States

Baltimore, Maryland, United States

Saint Louis, Missouri, United States

Saint Louis, Missouri, United States

Buffalo, New York, United States

New York, New York, United States

New York, New York, United States

Cincinnati, Ohio, United States

Columbus, Ohio, United States

Honolulu, Hawaii, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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4 stars
6
3 stars
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0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

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Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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