A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With… (NCT00000966) | Clinical Trial Compass
CompletedPhase 1
A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
United States45 participants
Plain-language summary
To evaluate the effectiveness and toxicity of oral azithromycin and pyrimethamine as acute therapy for toxoplasmic encephalitis in AIDS patients. To assess the toxicity and effectiveness of azithromycin alone as maintenance therapy.
Encephalitis caused by Toxoplasma gondii is the most frequent cause of focal central nervous system infection in patients with AIDS. Untreated, the encephalitis is fatal. Standard treatment for toxoplasmic encephalitis is associated with serious adverse effects. Thus, alternative treatments are needed.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.