FORTOVASE ROLL-OVER PROTOCOL FOR HIV+ ADULTS

Tulane University Of Louisiana, New Orleans LA

Investigators

Linked publications & trials

Abstract

This is a roll-over protocol intended to continue availability of study drugs for patients leaving Roche sponsored clinical trials (NV15355, NV15436 and M61003). Patients will continue on the antiretroviral regimen they were receiving on the last day of the Roche sponsored clinical trial preceding the roll-over protocol. The primary objective is to determine time to Virologic Relapse [two HIV-1 RNA > 400 copies/mL $ 10 days apart, following a virologic response (two consecutive values < 400 copies/mL $ 10 days apart)]. Patients will have achieved a virologic response during the Roche sponsored clinical trial preceding the roll-over protocol (as captured at the screening visit). The virologic response starts on the date of the first of the two consecutive values < 400 copies/mL and ends on the date of the first of the two consecutive values > 400 copies/mL. The secondary objective is to determine time to Virologic Relapse [two HIV-1 RNA > 50 copies/mL $ 10 days apart, following a virologic response (two consecutive values < 50 copies/mL days apart)]. Patients will have achieved a virologic response during the Roche sponsored clinical trial preceding the roll-over protocol. The virologic response starts on the date of the first of the two consecutive values < 50 copies/mL and ends on the date of the first of the two consecutive values > 50 copies/mL.