Phase 3 switch study with GS-9883/F/TAF & ABC/DTG/3TC in HIV-1 subject

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Switching from a Regimen of Dolutegravir and ABC/3TC, or a Fixed Dose Combination (FDC) of ABC/DTG/3TC to a FDC of GS-9883/F/TAF in HIV-1 Infected Subjects who are Virologically Suppressed

• IRAS ID

  195230

• Contact name

  Margaret Johnson

• Contact email

  Margaret.Johnson1@nhs.net

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2015-004025-14

• Clinicaltrials.gov Identifier

  NCT02603120

• Duration of Study in the UK

  1 years, 3 months, 3 days

• Research summary

  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 also to 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 and better clinical and virologic 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 determine whether switching to a once-daily fixed dose tablet of GS-9883/F/TAF FDC works as well as continuing a regimen of DTG and ABC/3TC as the once-daily fixed dose tablet of ABC/DTG/3TC (abacavir/dolutegravir/lamivudine). This study will also evaluate whether GS-9883/F/TAF maintains control of HIV-1 effectively compared to ABC/DTG/3TC.

  This study is sponsored by Gilead Sciences Inc. Approximately 520 participants will take part at approximately 105 sites globally. Approximately 30 subjects will be recruited from the UK. Participation will last 48 weeks, not including the screening period which may last up to 30 days. Participants will be required to visit the clinic at least 7 times (day 1, weeks 4, 8, 12, 24, 36 and 48). After 48 weeks on treatment, participants will complete a follow up visit and return to their standard care. Procedures involved include physical exams, vital signs, blood tests, ECGs, DXA scans and HIV related assessments.

  Participants will be selected by chance to receive 1 of the following:
  Treatment Arm 1: Approximately 260 participants will receive GS-9883/F/TAF plus placebo to match ABC/DTG/3TC
  Treatment Arm 2: Approximately 260 participants will receive ABC/DTG/3TC plus placebo to match GS-9883/F/TAF

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/0039

• Date of REC Opinion

  18 Feb 2016

• REC opinion

  Further Information Favourable Opinion