CAB LA + RPV LA vs BIK in virologically suppressed HIV-1 participants

• Research type

  Research Study

• Full title

  A Phase IIIb, Randomized, Multicenter, Active-controlled, Parallel-group, Non-inferiority, Open-label Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine administered every two months from a Bictegravir/emtricitabine/tenofovir alafenamide Single Tablet Regimen in HIV-1 Infected Adults who are Virologically Suppressed

• IRAS ID

  285588

• Contact name

  Andrew Ustianowski

• Contact email

  Andrew.Ustianowski@mft.nhs.uk

• Sponsor organisation

  GSK on behalf of ViiV Healthcare

• Eudract number

  2020-002623-11

• Clinicaltrials.gov Identifier

  NCT04542070

• Duration of Study in the UK

  2 years, 5 months, days

• Research summary

  RESEARCH SUMMARY:
  This ViiV-Healthcare funded study is looking at how safe and how well treatment with a long acting injection of Cabotegravir (CAB) and Rilpivirine (RPV) every 2 months, compares to treatment with a single tablet per day of Biktarvy. This study is being performed in adults infected with HIV-1, whose disease is already managed. The injection works by stopping the HIV virus from being able to make more copies of itself.

  The study will include 654 participants in 14 countries, approximately 17 of which will be in the UK. Eligible participants must be at least 18 years old with a viral load which is undetectable (<50 c/mL) at screening and for at least 6 months previously. Participants must be taking Biktarvy and for at least 6 months prior to screening.

  Following the 1st visit, participants will enter a 35-day period to make sure they qualify for the study. If successful, they will be randomly given (in a 2:1 ratio) either the injection or continue to receive Biktarvy. Participants will know which treatment they are receiving. The first injection is followed 1 month later by the second injection, then injections are every 2 months.

  The first year of the study is followed by an additional phase with visits every 2 months, during which the injections will continue to be provided, including to eligible Biktarvy patients who want to switch. This additional phase will continue until the injection combination is locally approved and available on prescription (expected by Q1 2022), participants no longer benefit from the treatment, discontinue from the protocol, or development of the treatment is terminated.

  Participants who discontinue with the injections go into a follow-up period which lasts for 1-year, with visits every 3 months.

  LAY SUMMARY OF STUDY RESULTS:
  A plain language summary which describes the study and the results has been included on the website: https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.trialsummaries.com%2FStudy%2FStudyDetails%3Fid%3D11463%26tenant%3DMT_VIV_9011&data=05%7C01%7Ccoventryandwarwick.rec%40hra.nhs.uk%7Cfb7f72ef1ee14481f27208dbc0ea936c%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638315885993272118%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=EQnJKr9srBgFjRPIDrqoUn26yFBR0o0zVtV3w76oG6E%3D&reserved=0

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  20/WM/0250

• Date of REC Opinion

  4 Nov 2020

• REC opinion

  Further Information Favourable Opinion