Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

  • STATUS
    Not Recruiting
  • participants needed
    750
  • sponsor
    ViiV Healthcare
Updated on 28 April 2021
GSK Investigational Site (1.5 mi away) Contact
hysterectomy
immunodeficiency
tenofovir
dolutegravir
lamivudine
antiviral drugs
hiv-1 rna measurement

Summary

The aim of the study is to establish if human immunodeficiency virus type 1 (HIV-1) infected adult subjects 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 subject 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, ART-experienced, virologically suppressed subjects. 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). Approximately 550 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 subjects will switch to DTG + 3TC up to Week 200.

Details
Condition HIV infection, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus, Infection, Human Immunodeficiency Virus
Treatment DTG + 3TC, TAF based regimen (TBR)
Clinical Study IdentifierNCT03446573
SponsorViiV Healthcare
Last Modified on28 April 2021

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