ViiV starts Phase III TANGO study switching patients from triple therapy to combination Tivicay and Epivir as a treatmant for HIV-1.
ViiV Healthcare announced the start of a phase III study designed to establish if adults with HIV-1 with current virologic suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs are able to maintain viral suppression upon switching to a two-drug regimen (2DR) of dolutegravir (TIVICAY) and lamivudine (EPIVIR).
TANGO will seek to enrol approximately 550 adults with HIV-1, from clinical trial sites in North America, Europe, Australia, and Japan. The TANGO trial is designed to demonstrate the non-inferior antiviral activity of switching to dolutegravir and lamivudine compared to continuation of a TAF-based regimen over 48 weeks in virologically suppressed subjects. TANGO will characterise patient satisfaction as well as the long-term antiviral activity, tolerability and safety of a 2DR of dolutegravir and lamivudine through to 96 weeks.
The TANGO study follows the GEMINI studies� investigation of the 2DR of dolutegravir and lamivudine in treatment-na�ve patients with HIV-1. Results from those trials are anticipated later this year.