Completed

Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii

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What is being tested

Pyrimethamine

+ Leucovorin calcium

+ Zidovudine

Drug
Who is being recruted

Abscess+27

+ Blood-Borne Infections

+ Neuroinflammatory Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AbscessBlood-Borne InfectionsNeuroinflammatory DiseasesUrogenital DiseasesGenital DiseasesBrain AbscessBrain DiseasesCentral Nervous System DiseasesCentral Nervous System InfectionsCoccidiosisCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsNervous System DiseasesParasitic DiseasesProtozoan InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSuppurationVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsCentral Nervous System Parasitic InfectionsCentral Nervous System Protozoal InfectionsEncephalitisToxoplasmosisHIV InfectionsToxoplasmosis, Cerebral

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Memorial Sloan-Kettering Cancer Ctr.

New York, United StatesOpen Memorial Sloan-Kettering Cancer Ctr. in Google Maps

Unc Aids Crs

Chapel Hill, United States
Completed2 Study Centers