A Study of Azithromycin Plus Pyrimethamine in the Treatment of a Brain Infection in Patients With AIDS
A Dose-Escalation, Phase I/II Study of Oral Azithromycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
1 other identifier
interventional
45
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedAugust 26, 2008
October 1, 1994
November 2, 1999
August 25, 2008
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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:
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
SUNY - Stony Brook
Stony Brook, New York, 117948153, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, 10461, United States
Montefiore Med Ctr / Bronx Municipal Hosp
The Bronx, New York, 10467, United States
Bronx Veterans Administration / Mount Sinai Hosp
The Bronx, New York, 10468, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Related Publications (3)
Saba J, Morlat P, Raffi F, Hazebroucq V, Joly V, Leport C, Vilde JL. Pyrimethamine plus azithromycin for treatment of acute toxoplasmic encephalitis in patients with AIDS. Eur J Clin Microbiol Infect Dis. 1993 Nov;12(11):853-6. doi: 10.1007/BF02000407.
PMID: 8112357BACKGROUND. Kamarulzaman A, Hoy J. Effect of folinic acid on haematological toxicity during treatment of cerebral toxoplasmosis in patients with AIDS. Annu Conf Australas Soc HIV Med. 1995 Nov 16-19;7:68 (abstract no 68)
BACKGROUNDJacobson JM, Hafner R, Remington J, Farthing C, Holden-Wiltse J, Bosler EM, Harris C, Jayaweera DT, Roque C, Luft BJ; ACTG 156 Study Team. Dose-escalation, phase I/II study of azithromycin and pyrimethamine for the treatment of toxoplasmic encephalitis in AIDS. AIDS. 2001 Mar 30;15(5):583-9. doi: 10.1097/00002030-200103300-00007.
PMID: 11316995BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Luft B
- STUDY CHAIR
Remington J
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
August 26, 2008
Record last verified: 1994-10