Dataset from A Phase III, Randomized, Multicenter, Parallel-group, Non-inferiority Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Dolutegravir Plus Lamivudine in HIV-1 Infected Adults Who Are Virologically Suppressed

The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected
adult participants with current virologic suppression on a >=3-drug tenofovir alafenamide
(TAF) based regimen (TBR) remain suppressed upon switching to a two-drug regimen of
dolutegravir (DTG) 50 milligram (mg) + lamivudine (3TC) 300 mg. This study will also provide
important information regarding the safety and participant satisfaction with this two-drug
regimen. The primary objective of this trial is to demonstrate the non-inferior antiviral
activity of switching to DTG + 3TC once daily compared to continuation of TBR over 48 weeks
in HIV-1 infected, antiretroviral therapy (ART)-experienced, virologically suppressed
participants. This study also will characterize the long-term antiviral activity,
tolerability and safety of DTG + 3TC compared to TBR through Week 144 and characterize the
long-term antiviral activity, tolerability and safety of DTG + 3TC through Week 200.

This will be a 200-week, Phase III, randomized, open-label, active-controlled, multicenter,
parallel- group study. The study will include a screening phase (up to 28 days), a randomized
early switch phase (Day 1 up to Week 148), a randomized late switch phase (Week 148 up to
Week 200), and a continuation phase (post Week 200). HIV-1 infected adults on stable TBR will
be randomized 1:1 to switch to DTG + 3TC once daily for up to 200 weeks, or to continue their
TBR for 148 weeks, at which time and if HIV-1 ribonucleic acid (RNA) <50 copies per
milliliter (c/mL) at Week 144, these participants will switch to DTG + 3TC up to Week 200.

本研究旨在明确：接受以≥3种药物替诺福韦艾拉酚胺（tenofovir alafenamide, TAF）为基础方案（TBR）且当前实现病毒学抑制的人类免疫缺陷病毒1型（HIV-1）感染成人受试者，在转换为多替拉韦（dolutegravir, DTG）50毫克（mg）+拉米夫定（lamivudine, 3TC）300mg的双药方案后，是否仍可维持病毒学抑制。本研究还将为该双药方案的安全性及受试者满意度提供关键信息。本试验的主要目的是证实，在HIV-1感染、经抗反转录病毒治疗（antiretroviral therapy, ART）且病毒学受抑制的受试者中，相较于持续接受TBR方案，每日一次转换为DTG+3TC方案在48周内的抗病毒活性非劣效性。本研究还将评估至第144周时，DTG+3TC相较于TBR的长期抗病毒活性、耐受性与安全性，并评估至第200周时DTG+3TC的长期抗病毒活性、耐受性与安全性。

本研究为一项为期200周的III期、随机、开放标签、阳性对照、多中心平行组研究。研究流程包含筛查阶段（最长28天）、随机早期转换阶段（第1天至第148周）、随机晚期转换阶段（第148周至第200周）以及第200周后的延续随访阶段。接受稳定TBR方案的HIV-1感染成人受试者将按1:1比例随机分组：一组每日一次转换为DTG+3TC方案，最长持续给药至200周；另一组继续接受TBR方案至第148周，若该组受试者在第144周时HIV-1核糖核酸（RNA）<50拷贝/毫升（c/mL），则将其转换为DTG+3TC方案直至第200周。