HIV Infections Clinical Trial
Official title:
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS
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.
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.
;
Masking: Open Label, Primary Purpose: Treatment
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