Phase 3 study with GS-9883/F/TAF in HIV-1, treatment naïve subjects

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

• IRAS ID

  195696

• Contact name

  Margaret Johnson

• Contact email

  Margaret.Johnson1@nhs.net

• Sponsor organisation

  Gilead Sciences Inc

• Eudract number

  2015-003988-10

• Clinicaltrials.gov Identifier

  NCT02607956

• Duration of Study in the UK

  2 years, 3 months, 3 days

• Research summary

  Summary of Research

  The treatment of HIV-1 infection uses combination antiretroviral therapy (ART) to delay disease progression and prolong survival. The focus now is to develop drug regimens that prevent the development of drug resistance and improve patient adherence to the treatment. Adherence is improved by reducing the number of pills taken per day. It has been shown that once daily, single tablet regimens are associated with higher adherence to treatment, better clinical outcomes including fewer hospitalizations, improved patient satisfaction and excellent virological outcomes.

  This study will test an experimental drug called GS-9883/F/TAF (GS-9883/emtricitabine/tenofovir alafenamide) fixed dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to evaluate safety and to determine whether GS-9883/F/TAF as a fixed dose combination works as well as the treatment with the two drugs dolutegravir (DTG) (trade name Tivicay) and the FDC containing emtricitabine/tenofovir alafenamide (F/TAF). The study will also evaluate whether GS-9883/F/TAF maintains the control of HIV-1 infection effectively compared to DTG and F/TAF FDC.

  This study is sponsored by Gilead Sciences Inc. Approximately 600 participants will take part at approximately 100 sites globally. Approximately 32 subjects will be recruited from the UK. Participation will last 96 weeks, not including the screening period which may last up to 30 days. Participants will be required to visit the clinic at least 11 times (Day 1, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96). After 96 weeks on study treatment, participants will complete a follow up visit and return to the standard of care. Procedures involved include physical exams, vital signs, blood tests, ECGs and HIV related assessments.

  Participants will be selected by chance to receive 1 of the following:
  Treatment Arm 1: Approximately 300 participants will receive GS-9883/F/TAF plus placebo to match DTG and placebo to match F/TAF
  Treatment Arm 2: Approximately 300 participants will receive DTG and F/TAF plus placebo to match GS-9883/F/TAF

  Neither the participant nor the study doctor will know what treatment was assigned.

  Summary of Results

  The plain language summary (PLS) of this study will be made available in March 2022

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/0029

• Date of REC Opinion

  18 Feb 2016

• REC opinion

  Further Information Favourable Opinion