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Sponsors and Collaborators: |
Pfizer National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000966 |
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 |
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Toxoplasmosis, Cerebral HIV Infections |
Drug: Azithromycin Drug: Pyrimethamine Drug: Leucovorin calcium |
Phase I |
Study Type: | Interventional |
Study Design: | 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.
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:
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 | |
Nassau County Med Ctr | |
East Meadow, New York, United States, 11554 | |
SUNY - Stony Brook | |
Stony Brook, New York, United States, 117948153 | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Cornell Univ Med Ctr | |
New York, New York, United States, 10021 | |
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 | |
Bronx Veterans Administration / Mount Sinai Hosp | |
Bronx, New York, United States, 10468 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Luft B | |
Study Chair: | Remington J |
Study ID Numbers: | ACTG 156 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000966 |
Health Authority: | Unspecified |
Toxoplasmosis Toxoplasma Pyrimethamine Leucovorin Drug Evaluation |
Drug Therapy, Combination Encephalitis Administration, Oral Acquired Immunodeficiency Syndrome Azithromycin |
Pyrimethamine Protozoan Infections Sexually Transmitted Diseases, Viral Toxoplasmosis, Cerebral Acquired Immunodeficiency Syndrome Leucovorin Central Nervous System Diseases Brain Diseases Encephalitis Toxoplasmosis Immunologic Deficiency Syndromes |
Folic Acid Virus Diseases Calcium, Dietary Central Nervous System Infections HIV Infections Azithromycin Abscess Sexually Transmitted Diseases Suppuration Parasitic Diseases Retroviridae Infections |
Communicable Diseases Anti-Infective Agents Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Infection Central Nervous System Parasitic Infections Anti-Bacterial Agents Antimalarials Antiparasitic Agents Vitamins Therapeutic Uses |
Micronutrients RNA Virus Infections Vitamin B Complex Immune System Diseases Coccidiosis Growth Substances Nervous System Diseases Brain Abscess Enzyme Inhibitors Folic Acid Antagonists Pharmacologic Actions Central Nervous System Protozoal Infections Lentivirus Infections |