GSK 201147 Study

Purpose

The purpose of this Phase IIIb, randomized, open-label study is to determine the safety and efficacy of a new fixed -dose combination of abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) as a single tablet regimen compared with subjects taking their current combined antiretroviral therapy (cART) for the treatment of HIV-1 infected adults in whom the HIV-1 virus is currently suppressed. This study will help determine who is more likely to benefit and who is more likely to have side effects from the ABC/DTG/3TC combination.

Procedure

Participants will be randomized to one of 2 groups. One group will receive the study drug combination for 48 weeks; the other group will continue the current antiretroviral regimen which consists of 2 nucleoside reverse transcriptase inhibitors (NRTI) and a third agent ( a protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI) or integrase inhibitor (II)) for 24 weeks, and then switched to the study drug for another 24 weeks. Once enrolled, participants will be followed regularly at 4,8,16,24,28,32 and 40 weeks after assignment to a treatment group. During those visits, participants will have a limited exam, answer questionnaire about their health status and the HIV treatment Satisfaction Questionnaire (HIVTSQ) as well as have blood work done.

Who can participate?

We are seeking HIV-1 infected adults who are virologically suppressed.