This Phase II, randomized, placebo-controlled trial is designed to investigate whether therapeutic immunization during highly active antiretroviral therapy (HAART) induces elevations of HIV-specific memory T cells in HIV-1-infected individuals, and whether the quantity of these memory T cells correlate with the viral load set point following analytical treatment interruption (ATI). A total of 16 subjects will be enrolled and randomized to receive DermaVir patch (eight subjects) or DermaVir patch placebo (eight subjects).
Subjects are being randomized to receive either DermaVir patch (eight subjects per cohort) or placebo patch (eight subjects per cohort) every four weeks for three applications while receiving maximally suppressive HAART.
HAART will be discontinued at week nine for an ATI period of 20 weeks. The trial will employ a novel assay of memory T-cell function known as the precursors with high proliferative capacity assay developed by ViroStatics, the Italian partner of Genetic Immunity.
Julianna Lisziewicz, CEO of Genetic Immunity, said: “I look forward to obtaining results from this, our second in-progress Phase II trial for DermaVir. I believe results will be outstanding and closely correlate with those of our first Phase II trial underway in Germany and allow us to quickly move forward to Phase III in the not too distant future. When successful, DermaVir can become the first effective HIV immune-based treatment on the market within the next few years.”