- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000973
A Study of Pyrimethamine in the Treatment of Infection by a Certain Parasite in HIV-Positive Patients
Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii
To determine the manner in which pyrimethamine is metabolized and excreted in patients currently receiving zidovudine (AZT). An important goal of this measurement is to establish the optimal dose of pyrimethamine necessary to prevent the development of toxoplasmosis in AIDS patients or delay the subsequent return of toxoplasmic encephalitis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 treatment for a total of 22 days. Patients are given an initial dose of pyrimethamine followed by a lower dose given as a single oral daily dose for 21 days. Patients continue to receive AZT at the dose prescribed prior to enrollment in the study. Patients receive leucovorin calcium once a day. Neither the leucovorin calcium nor the AZT are provided through the study.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Ctr.
-
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- Unc Aids Crs
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: B Luft
Publications and helpful links
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Central Nervous System Infections
- Parasitic Diseases
- Coccidiosis
- Protozoan Infections
- Suppuration
- Central Nervous System Parasitic Infections
- Abscess
- Brain Abscess
- Central Nervous System Protozoal Infections
- Infections
- Toxoplasmosis
- Toxoplasmosis, Cerebral
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Antimetabolites
- Protective Agents
- Micronutrients
- Vitamins
- Calcium-Regulating Hormones and Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antidotes
- Vitamin B Complex
- Antimalarials
- Folic Acid Antagonists
- Leucovorin
- Calcium
- Levoleucovorin
- Zidovudine
- Pyrimethamine
Other Study ID Numbers
- ACTG 102
- 11077 (DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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