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A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

Last updated on March 14, 2019

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Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cerebral Toxoplasmosis, HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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Concurrent Medication:

Allowed:

- Aerosolized pentamidine for prophylaxis against Pneumocystis carinii pneumonia (PCP).

- Allowed during maintenance period (weeks 7 - 24):

- Zidovudine and other antiretrovirals available through treatment IND mechanisms,
ganciclovir, and maintenance doses of amphotericin (other investigational therapies
require permission from the study chair), steroids for the treatment of acute PCP.

- Isoniazid (INH) only for patients already on INH.

Patients must have the following:

- HIV infection or belong to high-risk group. Presumptive or definite diagnosis of
toxoplasmic encephalitis.

- Each patient, or his/her appropriate family member, or legal designee must be able to
understand and sign a written informed consent, in accordance with the local practices
at each site.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

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

- Coma.

- More than 72 hours of treatment for current episode of toxoplasmic encephalitis prior
to study entry.

- Central nervous system (CNS) lymphoma.

- Cerebral Kaposi's sarcoma.

- Active hepatitis or clinical jaundice.

- History of serious hypersensitivity or intolerance to any of the study drugs.

- Serum or cerebrospinal fluid (CSF) positive for cryptococcus antigen or culture.

- Malignancies requiring use of cytotoxic chemotherapy.

- Inability to take oral therapy reliably.

- Malabsorption syndrome.

Concurrent Medication:

Excluded:

- Opportunistic infection requiring either acute treatment or maintenance therapy with
azithromycin, erythromycin or other macrolides, sulfonamides, amphotericin, dapsone,
ganciclovir, antifolates, and other investigational agents except erythropoietin. For
first 6 weeks of treatment, patients may not receive treatment with erythromycin (or
other macrolides), sulfonamides, immunomodulators with the exception of alpha
interferon, lymphocyte replacement, cytotoxic chemotherapy, dapsone, ganciclovir,
rifampicin, coumadin, antiretrovirals, and investigational agents other than
erythropoietin.

Patients with the following are excluded:

- Negative HIV antibodies by a federally licensed ELISA, unless there is documentation
of a previously positive HIV culture or p24 antigen.

- Infections of the central nervous system.

- Malignancies requiring the use of cytotoxic chemotherapy.

- Any medical or social condition that, in the opinion of the investigator, would
adversely affect participation and/or compliance in this study.

NCT00000966
Pfizer
Completed
A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS

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