Clinical Trials for VS411

VS411, ViroStatics' Proof-of Concept product for the use of AV-HALTs in the treatment of HIV/AIDS, combines the antiviral activity of low-dose, slow-release dideoxyinosine with the antiproliferative properties of low-dose hydroxycarbamide.  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 hydroxycarbamide’s immunomodulating properties and the combination’s favorable resistance profile against dideoxyinosine-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 Completed






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