A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in 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.
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Remington JS
Study Chair
United States: Federal Government
ACTG 077P
NCT00000674
August 1992
Name | Location |
---|---|
USC CRS | Los Angeles, California 90033 |
Stanford CRS | Palo Alto, California 94305 |
Ucsd, Avrc Crs | San Diego, California |
Univ. of Miami AIDS CRS | Miami, Florida 33136 |
Johns Hopkins Adult AIDS CRS | Baltimore, Maryland 21287 |
Washington U CRS | St. Louis, Missouri |
SUNY - Buffalo, Erie County Medical Ctr. | Buffalo, New York 14215 |
NY Univ. HIV/AIDS CRS | New York, New York 10016 |
Memorial Sloan-Kettering Cancer Ctr. | New York, New York 10021 |
Cornell University A2201 | New York, New York 10021 |
Unc Aids Crs | Chapel Hill, North Carolina 27599 |
Duke Univ. Med. Ctr. Adult CRS | Durham, North Carolina 27710 |
Pitt CRS | Pittsburgh, Pennsylvania 15213 |