Search / Trial NCT00000973

A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients

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

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Trial Information

Current as of December 10, 2023

Completed

Keywords

Toxoplasmosis Toxoplasma Pyrimethamine Leucovorin Drug Evaluation Encephalitis Zidovudine

Description

Encephalitis caused by Toxoplasma gondii has emerged as the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. The best treatment for this disease has not been determined. Presently it is standard practice to administer a combination of pyrimethamine and sulfadiazine. Little is known about the pharmacokinetics of pyrimethamine in patients with AIDS receiving AZT. Furthermore, there are reports that patients already exposed to toxoplasmosis may not have uniform absorption of pyrimethamine. Patients receive the study tre...

Gender

All

Eligibility criteria

  • Inclusion Criteria
  • Concurrent Medication:
  • Allowed:
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia prophylaxis.
  • Isoniazid not initiated during study period.
  • Methadone maintenance.
  • Required:
  • Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day.
  • Exclusion Criteria
  • Co-existing Condition:
  • Patients with the following conditions or symptoms are excluded:
  • Prior history of toxoplasmic encephalitis.
  • Unable to take oral medication reliably or have a malabsorption syndrome (i.e., 3 or more loose stools/day for at least 4 weeks associated with an unintentional weight loss of = or > 10 percent of body weight).
  • History of sensitivity to the study medications.
  • Concurrent Medication:
  • Excluded:
  • Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy.
  • Medications such as aspirin, benzodiazepines, cimetidine, indomethacin, morphine, and sulfonamides should be avoided.
  • Concurrent Treatment:
  • Excluded:
  • Lymphocyte replacement.
  • Patients with the following are excluded:
  • Any medical or social condition that, in the opinion of the investigator, would adversely affect either participation or compliance in the study.
  • Diagnosis of AIDS and febrile and have evidence of another serious opportunistic infection or central nervous system impairment.
  • Prior Medication:
  • Excluded:
  • Maintenance therapy for opportunistic infections with macrolides or sulfonamides, immunomodulators, rifampin, amphotericin, dapsone, ganciclovir, antifolates, probenecid, benzodiazepines, nephrotoxins, and experimental cytotoxic chemotherapy within past 14 days.
  • Prior Treatment:
  • Excluded:
  • Lymphocyte replacement within past 14 days.
  • Patients have the following symptoms and conditions:
  • Laboratory evidence of HIV infection.
  • Serological evidence of exposure to Toxoplasma gondii, but no clinical evidence of active toxoplasmic infection.
  • Able to understand and sign a written informed consent.
  • Either homosexual male or intravenous drug user.
  • Required:
  • Stable prescribed dose of zidovudine (AZT) of at least 500 mg/day for 4 weeks.
  • Intravenous drug abuse.

Attachments

readout_NCT00000973_2023-12-10.pdf

4.5 MB

NCT00000973_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

New York, New York, United States

Chapel Hill, North Carolina, 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

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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?

Michael Foster
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?

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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