204862 Phase 3 switch study -TAF regimen to DTG + 3TC in HIV-1 adults

• Research type

  Research Study

• Full title

  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

• IRAS ID

  229054

• Contact name

  Amanda Clarke

• Contact email

  amanda.clarke@bsuh.nhs.uk

• Sponsor organisation

  ViiV Healthcare UK Limited

• Eudract number

  2015-004401-17

• Duration of Study in the UK

  2 years, 10 months, 31 days

• Research summary

  Summary of Researh
  This is a clinical research study to determine the effectiveness, safety and tolerability of two approved medicines dolutegravir (DTG) plus lamivudine (3TC) taken together as a complete regimen, compared with participants taking their current tenofovir alafenamide (TAF) based regimen (TBR) of 3 or more drugs, for the treatment of HIV-1 infected adults in whom the virus is currently suppressed.

  Three drug antiretroviral treatment (ART) regimens have led to a remarkable decline in deaths and complications in HIV patients, resulting in longer life expectancy. However, this has been accompanied by higher rates of non-AIDS – defining events (NADEs) such as heart disease, liver disease and cancer. As ARTs are required life long, there is an unmet need for streamlined regimens that can minimize drug-related toxicities and drug-drug interactions while maintaining viral suppression. It is thought that the two drug therapy,DTG+3TC, has the potential to do this.

  This research study will include approximately 766 participants located at about 227 sites globally, who are on a stable TBR. Potential participants will enter a screening period (of up to 28 days) to determine eligibility to enter this 2 year study. On day 1, eligible participants will be randomised 1:1 to either switch to DTG+3TC once daily for up to 100 weeks, or to continue their TBR for 52 weeks, after which time (depending on HIV-1 levels in the blood), these participants will switch to DTG +3TC until Week 100. After Week 100, the main study will end and participants may choose to stay on DTG+3TC and come for visits every 12 weeks either until the drug becomes available or if it no longer works for the participant.

  The study involves assessments and procedures including: physical exams, cardiovascular risk assessment, vital signs, an electrocardiogram (ECG), questionnaires, blood and urine tests and questions about how the participant is feeling and about the medications they are taking.

  This study is sponsored by ViiV Healthcare.

  Summary of Results
  PLS link for week 144 is available at:
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbbQf79heaxA0D-2FNhi7Sw-2B-2BVoqpAOIPNkvgxaK0UW6aAghNVLHq0mH1-2FvyS2PWTHmTMTH0sThijvSIbeNBvOBSEYOzTdN6JD3omrqqyZB0rAoc0wW_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL7iYQTBCfgeLZV4RU-2Fs5PC8QzfCkWPofwOwl3xn90Gi0uGrhVucmDzLFMJhBMWjBh3BJ8Vf3lBHEH8CqtEOTa-2BugxJxmwMmuucMjQ7OqVkDMhKr9WBOCMTt5gdSVE-2BRNXcLizBPoBKtUkU1q7em1HPQUbfjN-2BV1l-2BGWIo8WS3wmA-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C17138f1d80af43dbbbc708dafd580a5b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638100851811592663%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=4jvNcBpdO6cLxNjyYBa8fVjaFl%2BzK%2FxtME5Fz0zsELo%3D&reserved=0
  https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbXK2HOTSVx-2BJ0k5Lm5yCbQe5S7B98DZurFjv118tpArb9aY5rD35Zb4Dy4oN-2Fcvnzg-3D-3DVYEH_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL7iYQTBCfgeLZV4RU-2Fs5PCx27agUQB1VNFyRatCz6ra1p9gtfvvY7tlxM0I6x6qclBHnQpXGg9yP3abQsFlLQyi2DXWXcU4o5fYKfEEOfVPfPIJfqOgOvZfmv7YsHfTAZJIuEqFTrKabUbVG3hA-2B1qYVzJIY-2FyDZe51wyAzyXeig-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C17138f1d80af43dbbbc708dafd580a5b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638100851811592663%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=pl%2FDTbURL9PoyzBm%2F7q%2FQZl7fu1zNvyOcS0nEGKP6po%3D&reserved=0

  PLS link for week 196 will be available within 12 months of LPLV (LPLV was 03/05/2022)

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  17/EM/0281

• Date of REC Opinion

  19 Sep 2017

• REC opinion

  Further Information Favourable Opinion