CASG 204 (DMID#98-022) 

"Long Term Treatment of HSE with Valtrex"

 CLOSED

This is a phase III, double-blind placebo controlled study among 12 years and older patients with proven Herpes Simplex Encephalitis (HSE) currently completed or being treated with IV Acyclovir in order to determine if treatment with 2g of Valacyclovir given 3x/day by mouth for 90 days will be beneficial, safe after completing IV Acyclovir treatment, will reduce brain swelling, nervous system damage and if it can increase survival with or without mild neuropsychological impairment. This research is being conducted because Valacyclovir has not been approved by the FDA for treatment of HSE however; approved for other herpes simplex virus infections and for shingles.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.

 

CASG 209 (DMID#04-047) 

"A Pilot Study To Evaluate the Safety, Tolerability and Antiviral Activity of Cidofovir in Renal Transplant Patients with BK Virus-Associated Nephropathy"

CLOSED

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study to evaluate the safety, tolerability, MTD, PK/PD and preliminary effectiveness of cidofovir in kidney transplant recipients with biopsy-confirmed BKVN.  Immunosuppression will be reduced according to suggested guidelines in all patients.  The study consists of three dose cohorts (0.25 mg/kg, 0.5 mg/kg and 1.0 mg/kg); each cohort will consist of up to 12 subjects randomized 2:1 to receive either cidofovir or placebo (saline) to define the maximum tolerated dose (MTD) among the three specified doses of cidofovir.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.

 

CASG 211 (DMID#03-114)

"Natural History of West Nile Virus Infection"

CLOSED  

This study will examine how West Nile virus (WNV) infection affects the body. Some people infected with WNV have no symptoms. In others, symptoms may vary from fever and headache to a polio-like syndrome with paralysis, to coma and brain changes like those of a stroke. Many patients recover with no lasting effects, while a few can have long-lasting neurological damage or may die. This study will collect clinical, laboratory, diagnostic, and radiographic information on people thought to have WNV to better understand the disease.

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If you need more information please contact the CASG Central Unit at 1-877-975-7280.