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| Sponsor: | Pfizer |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000966 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Toxoplasmosis, Cerebral HIV Infections |
Drug: Azithromycin Drug: Pyrimethamine Drug: Leucovorin calcium |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Dose-Escalation, Phase I/II Study of Oral Azithromycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS |
| Estimated Enrollment: | 45 |
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.
Patients with toxoplasmosis are given azithromycin at doses starting at the lowest dose for the first cohort, an intermediate dose for the second cohort, and a higher dose for the third cohort. Subsequent cohorts may receive azithromycin in increased dosage, if needed to determine the MTD. All patients also receive pyrimethamine. Folinic acid is also provided for as long as patients receive pyrimethamine. Patients are evaluated for clinical response to treatment at days 3, 7, and 14, and weekly for 6 weeks. Maintenance treatment with azithromycin continues for an additional 24 weeks. Patients who complete the study period without relapse or significant toxicity are offered continued therapy by the drug company and are followed for survival and relapse on a monthly basis for 1 year. After the MTD is determined, a subsequent cohort may be added for special studies.
Eligibility| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have the following:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Contacts and Locations| United States, California | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| United States, Florida | |
| Univ of Miami School of Medicine | |
| Miami, Florida, United States, 331361013 | |
| United States, Massachusetts | |
| Univ of Massachusetts Med Ctr | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, New York | |
| Bronx Veterans Administration / Mount Sinai Hosp | |
| Bronx, New York, United States, 10468 | |
| Bronx Municipal Hosp Ctr/Jacobi Med Ctr | |
| Bronx, New York, United States, 10461 | |
| Montefiore Med Ctr / Bronx Municipal Hosp | |
| Bronx, New York, United States, 10467 | |
| Nassau County Med Ctr | |
| East Meadow, New York, United States, 11554 | |
| Cornell Univ Med Ctr | |
| New York, New York, United States, 10021 | |
| Bellevue Hosp / New York Univ Med Ctr | |
| New York, New York, United States, 10016 | |
| SUNY - Stony Brook | |
| Stony Brook, New York, United States, 117948153 | |
| United States, South Carolina | |
| Julio Arroyo | |
| West Columbia, South Carolina, United States, 29169 | |
| Study Chair: | Luft B | |
| Study Chair: | Remington J |
More Information
| ClinicalTrials.gov Identifier: | NCT00000966 History of Changes |
| Other Study ID Numbers: | ACTG 156 |
| Study First Received: | November 2, 1999 |
| Last Updated: | August 25, 2008 |
| Health Authority: | Unspecified |
|
Toxoplasmosis Toxoplasma Pyrimethamine Leucovorin Drug Evaluation |
Drug Therapy, Combination Encephalitis Administration, Oral Acquired Immunodeficiency Syndrome Azithromycin |
|
HIV Infections Acquired Immunodeficiency Syndrome Encephalitis Toxoplasmosis Toxoplasmosis, Cerebral Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Central Nervous System Viral Diseases |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Central Nervous System Infections Coccidiosis Protozoan Infections Parasitic Diseases Brain Abscess Abscess Suppuration Infection Central Nervous System Protozoal Infections Central Nervous System Parasitic Infections Leucovorin Levoleucovorin |