Clinical Trials for VS411

VS411, ViroStatics' lead compound for the treatment of HIV/AIDS, combines the antiviral activity of didanosine (ddI) with the cytostatic propoerties of low-dose hydroxyurea (HU). The two agents, each of which have been employed in the clinical setting for many years, have been formulated together in a fixed dose combination product known as VS411. Beneficial synergies between the drugs’ mechanisms of action, combined with HU’s immunomodulating properties and the combination’s favorable resistance profile against ddI-resistant HIV, allow the investigation of lower doses of each drug than are currently prescribed, potentially minimizing the complexity, toxicity and cost of treatment while maintaining therapeutic efficacy.

If you would like additional information about any of the studies listed below, please contact:

Michael Stevens, PharmD
Chief Development Officer

116 Village Boulevard Suite 200 - Princeton, NJ 08540
Phone: +1 609 951-2206 - Mobile: +1 609 213-5287
M.Stevens@ViroStatics.com
Protocol No.
Name/Description Phase
Status
VS411-C101
A Phase I, open label, randomized, single dose, 4-way crossover trial in healthy subjects to determine the fasted and non-fasted oral bioavailability of didanosine (ddI) and hydroxyurea (HU) co-formulated as VS411 and administered as 2 different formulations, compared to commercially available ddI and HU, given simultaneously.
I
Completed
VS411-C201
A randomized double-blind dose-finding phase IIa study of VS411 for HIV-1 infection.
IIa
Enrollment completed December 2008






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