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Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii


Phase 1
18 Years
N/A
Not Enrolling
Both
Toxoplasmosis, Cerebral, HIV Infections

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Trial Information

Pyrimethamine Pharmacokinetics in HIV Positive Patients Seropositive for Toxoplasma Gondii


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

B Luft

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 102

NCT ID:

NCT00000973

Start Date:

Completion Date:

March 1995

Related Keywords:

  • Toxoplasmosis, Cerebral
  • HIV Infections
  • Toxoplasmosis
  • Toxoplasma
  • Pyrimethamine
  • Leucovorin
  • Drug Evaluation
  • Encephalitis
  • Zidovudine
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • HIV Seropositivity
  • Toxoplasmosis
  • Toxoplasmosis, Cerebral

Name

Location

Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Unc Aids CrsChapel Hill, North Carolina  27599