The effect of antiretroviral intensification with dolutegravir on residual virus replication in HIV-infected individuals: a randomised, placebo-controlled, double-blind trial

Publication date: Available online 8 April 2018 Source:The Lancet HIV Author(s): Thomas A Rasmussen, James H McMahon, J Judy Chang, Jennifer Audsley, Ajantha Rhodes, Surekha Tennakoon, Ashanti Dantanarayana, Tim Spelman, Tina Schmidt, Stephen J Kent, Vincent Morcilla, Sarah Palmer, Julian H Elliott, Sharon R Lewin Background Whether ongoing virus replication occurs in HIV-infected individuals on antiretroviral therapy (ART) is unclear; therefore, whether residual virus replication is a barrier to achieving a cure for HIV is also unknown. We aimed to establish whether ART intensification with dolutegravir would reveal or affect residual virus replication in HIV-infected individuals on suppressive treatment. Methods In this randomised, placebo-controlled, double-blind trial, we enrolled HIV-infected adults (aged 18 years and older) receiving combination ART (at least three agents) for at least 3 years from the Alfred Hospital and Melbourne Sexual Health Centre, Melbourne, VIC, Australia. Eligible participants had fewer than 50 copies per mL HIV-1 plasma RNA for more than 3 years and fewer than 20 copies per mL at screening and two CD4 counts higher than 350 cells per μL in the previous 24 months including screening. Participants were randomly assigned (1:1) to receive 50 mg oral dolutegravir or placebo once a day for 56 days in addition to background ART. Follow-up was done at days 1, 3, 7, 14, 28, 56, and 84. The primary outcome was the change from baseline i...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research