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Sponsors and Collaborators: |
Upjohn National Institute of Allergy and Infectious Diseases (NIAID) Glaxo Wellcome |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000674 |
To collect information on the effectiveness and toxicity of clindamycin plus pyrimethamine and leucovorin calcium for the treatment of acute toxoplasmic encephalitis in adult patients with AIDS. Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
Condition | Intervention |
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Toxoplasmosis, Cerebral HIV Infections |
Drug: Pyrimethamine Drug: Leucovorin calcium Drug: Clindamycin |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS |
Estimated Enrollment: | 30 |
Toxoplasmic encephalitis (encephalitis caused by Toxoplasma gondii) is the most frequent cause of focal central nervous system infection in patients with AIDS. If untreated, the encephalitis is fatal. At present, it is standard practice to give a combination of pyrimethamine and sulfadiazine to treat toxoplasmic encephalitis. The high frequency of sulfonamide-induced toxicity in AIDS patients often makes completion of a full course of therapy difficult. There is some information that high doses of parenteral (such as by injection) clindamycin used with pyrimethamine may be as effective as pyrimethamine plus sulfadiazine in the management of the acute phase of toxoplasmic encephalitis in patients with AIDS. Administration of parenteral clindamycin for prolonged periods of time, however, is costly, requires hospitalization, and is inconvenient for the patient. There is some indication that treatment of AIDS patients with acute toxoplasmic encephalitis with oral clindamycin may be effective. Leucovorin calcium is useful in preventing pyrimethamine-associated bone marrow toxicity.
Amended: Projected accrual increased to 50 patients. Original design: Patients receive study medications for a total of 6 weeks unless there are intervening events that require the discontinuation of study therapy. Patients are initially treated in the hospital (minimum of 7 days). Patients who are considered responders at day 7 may complete therapy on an outpatient basis. Nonresponders at day 7 may also be managed on an outpatient basis when it is medically appropriate.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients are admitted into the study if they have:
Allowed:
AMENDED:
Prior Medication:
Allowed if liver enzymes stable for 6 weeks prior to study entry:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Study Chair: | Remington JS | |
Study Chair: | Luft B |
Study ID Numbers: | ACTG 077 PILOT |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000674 |
Health Authority: | Unspecified |
Toxoplasmosis AIDS-Related Opportunistic Infections Pyrimethamine Leucovorin Drug Evaluation |
Drug Therapy, Combination Encephalitis Acquired Immunodeficiency Syndrome Clindamycin |
Pyrimethamine Opportunistic Infections Sexually Transmitted Diseases, Viral Clindamycin Toxoplasmosis, Cerebral Leucovorin Brain Diseases AIDS-Related Opportunistic Infections Suppuration Parasitic Diseases Retroviridae Infections Protozoan Infections Clindamycin-2-phosphate |
Acquired Immunodeficiency Syndrome Central Nervous System Diseases Immunologic Deficiency Syndromes Toxoplasmosis Encephalitis Virus Diseases Folic Acid Calcium, Dietary Central Nervous System Infections HIV Infections Abscess Sexually Transmitted Diseases |
Anti-Infective Agents Antiprotozoal Agents Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Central Nervous System Viral Diseases Infection Central Nervous System Parasitic Infections Anti-Bacterial Agents Antimalarials Antiparasitic Agents Therapeutic Uses Vitamins 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 Protein Synthesis Inhibitors Central Nervous System Protozoal Infections Lentivirus Infections |