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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000973 |
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.
Condition | Intervention | Phase |
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Toxoplasmosis, Cerebral HIV Infections |
Drug: Pyrimethamine Drug: Leucovorin calcium Drug: Zidovudine |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Pharmacokinetics Study |
Official Title: | Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii |
Estimated Enrollment: | 26 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Required:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Patients have the following symptoms and conditions:
Required:
Intravenous drug abuse.
United States, California | |
Palo Alto Veterans Adm Med Ctr / Stanford Univ | |
Palo Alto, California, United States, 94304 | |
United States, New York | |
SUNY - Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
Mem Sloan - Kettering Cancer Ctr | |
New York, New York, United States, 10021 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
United States, North Carolina | |
Univ of North Carolina | |
Chapel Hill, North Carolina, United States, 275997215 |
Study Chair: | B Luft |
Study ID Numbers: | ACTG 102 |
Study First Received: | November 2, 1999 |
Last Updated: | July 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00000973 |
Health Authority: | United States: Federal Government |
Toxoplasmosis Toxoplasma Pyrimethamine Leucovorin |
Drug Evaluation Encephalitis Zidovudine |
Pyrimethamine Protozoan Infections Sexually Transmitted Diseases, Viral Toxoplasmosis, Cerebral Acquired Immunodeficiency Syndrome Zidovudine Leucovorin Central Nervous System Diseases Brain Diseases Encephalitis Toxoplasmosis Immunologic Deficiency Syndromes |
Folic Acid Virus Diseases Calcium, Dietary Central Nervous System Infections HIV Seropositivity HIV Infections Abscess Sexually Transmitted Diseases Suppuration Parasitic Diseases Retroviridae Infections |
Antimetabolites Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Central Nervous System Parasitic Infections Reverse Transcriptase Inhibitors Antimalarials Antiparasitic Agents Anti-Retroviral Agents Vitamins Therapeutic Uses |
Micronutrients Nucleic Acid Synthesis Inhibitors RNA Virus Infections Anti-HIV Agents Vitamin B Complex Immune System Diseases Coccidiosis Growth Substances Nervous System Diseases Brain Abscess Enzyme Inhibitors Folic Acid Antagonists Antiviral Agents Pharmacologic Actions Central Nervous System Protozoal Infections |