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Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients


Phase 2
13 Years
N/A
Not Enrolling
Both
Toxoplasmosis, Cerebral, HIV Infections

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Trial Information

Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients


Cerebral toxoplasmosis is one of the most frequently encountered opportunistic infections in
the course of AIDS. The mortality (death) rate is estimated to be greater than 50 percent.
Pyrimethamine is a drug that appears promising for the primary prevention of cerebral
toxoplasmosis in HIV-infected patients.

AMENDED: 04-04-91 On the first day of therapy, a loading dose is given. After the first day,
patients take pyrimethamine or placebo 3 times a week. Patients also take leucovorin calcium
orally three times weekly. Enrollment occurs over approximately 12 months. All patients are
followed on study until a common study close-out date and final analysis of the study. It
is anticipated that this common close-out will occur when the mean duration of time on study
therapy will be 3 years (approximately in January, 1994).

ORIGINAL design: On the first day of treatment, patients receive a loading dose of
pyrimethamine or placebo, plus of leucovorin calcium. After the first day, patients take
pyrimethamine or placebo three times a week. Patients also take folinic acid orally three
times weekly. The mean duration of study participation is 3 years.

Inclusion Criteria


Inclusion Criteria

Concurrent Medication:

Allowed:

- Zidovudine (AZT), didanosine (ddI), dideoxycytidine (ddC), erythropoietin (Eprex),
other agents granted Treatment IND or expanded access status.

- Investigational triazoles.

- Pentamidine for primary prophylaxis of Pneumocystis carinii pneumonia (PCP).

Patients with the following are excluded:

- History of cerebral toxoplasmosis or toxoplasmosis infection in any other organ or
tissue.

- Focal neural abnormalities (except peripheral neuropathy) or mass lesions on a
previous computerized tomography (CT) scan or magnetic resonance image (MRI), unless
subsequent workup rules out toxoplasmosis, in which case abnormalities must have been
stable for at least 2 months.

- Known or suspected allergy or severe intolerance to study drugs.

Patients must have:

- Positive toxoplasma serology.

- HIV infection.

- Willingness and ability to comply with the protocol and capability of giving written
informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Current diagnosis of cerebral toxoplasmosis or toxoplasmosis infection in any other
organ or tissue.

- Known or suspected allergy or severe intolerance to study drugs.

Concurrent Medication:

Excluded:

- Anticoagulants. Other antifolates, sulfonamides, fansidar, macrolides,
5-fluorouracil, dapsone, or any other agent with known activity against Toxoplasma
gondii.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Prevention

Principal Investigator

BJ Luft

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 154

NCT ID:

NCT00000643

Start Date:

Completion Date:

May 1994

Related Keywords:

  • Toxoplasmosis, Cerebral
  • HIV Infections
  • Toxoplasmosis
  • Pyrimethamine
  • Leucovorin
  • Drug Evaluation
  • Acquired Immunodeficiency Syndrome
  • AIDS-Related Complex
  • Brain Diseases
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Toxoplasmosis
  • Toxoplasmosis, Cerebral

Name

Location

Stanford CRSPalo Alto, California  94305
Harbor-UCLA Med. Ctr. CRSTorrance, California  90502
Univ. of Miami AIDS CRSMiami, Florida  33136
Northwestern University CRSChicago, Illinois  60611
Rush Univ. Med. Ctr. ACTG CRSChicago, Illinois  60612
Indiana Univ. School of Medicine, Infectious Disease Research ClinicIndianapolis, Indiana  46202
Tulane Med. Ctr. - Charity Hosp. of New Orleans, ACTUNew Orleans, Louisiana  70112
Johns Hopkins Adult AIDS CRSBaltimore, Maryland  21287
Bmc Actg CrsBoston, Massachusetts  02118
University of Minnesota, ACTUMinneapolis, Minnesota  
St. Louis ConnectCare, Infectious Diseases ClinicSt Louis, Missouri  63112
Washington U CRSSt. Louis, Missouri  
NJ Med. School CRSNewark, New Jersey  
SUNY - Buffalo, Erie County Medical Ctr.Buffalo, New York  14215
NY Univ. HIV/AIDS CRSNew York, New York  10016
Memorial Sloan-Kettering Cancer Ctr.New York, New York  10021
Cornell University A2201New York, New York  10021
Beth Israel Med. Ctr. (Mt. Sinai)New York, New York  10003
Univ. of Rochester ACTG CRSRochester, New York  14642
Unc Aids CrsChapel Hill, North Carolina  27599
Duke Univ. Med. Ctr. Adult CRSDurham, North Carolina  27710
Univ. of Cincinnati CRSCincinnati, Ohio  45267
Case CRSCleveland, Ohio  44106
Pitt CRSPittsburgh, Pennsylvania  15213