Cell-Delivered Gene Transfer Shows Promise as HIV-1 Therapy

February 16, 2009 — A phase 2 clinical trial has demonstrated the safety of cell-delivered gene transfer for treating patients with HIV. Published online February 15 in Nature Medicine, the new study is the "first randomized, double-blind, placebo-controlled, phase 2 cell-delivered gene transfer clinical trial." The treated patients experienced no treatment-related adverse events, and CD4+ lymphocyte counts were higher in treated patients through 100 weeks of follow-up.

"Our study was the first to demonstrate...the feasibility of this approach to decrease HIV viral replication and to improve CD4 T cells (immune cells) in HIV-infected patients when antiretroviral therapy is stopped...compared to those who did not get this gene therapy," said first author Ronald T. Mitsuyasu, MD, professor of medicine and director of the University of California–Los Angeles Center for Clinical AIDS Research and Education, in an email to Medscape Pathology & Lab Medicine.