T-20 (enfuvirtide) versus Optimized Regimen Only (TORO 1) Study 1 Efficacy at week 24 in the Intention-to-Treat population
Lalezari et al., N. Engl. J. Med. 348 (29 May 2003)
Patients from 48 sites in North and South America with at least six months of previous treatment with
antiretroviral drugs, and with ? 5000 copies of HIV-1 RNA per ml of plasma were assigned in a 2:1 ratio to
receive enfuvirtide plus an optimized background regimen of 3 to 5 antiretroviral drugs or such regimen
alone (control group). Enfuvirtide (90 mg) was administered twice daily by subcutaneous injection.