TDF-Containing Regimen to E/C/F/TAF FDC in HIV-1 Adults Aged ≥60 Years

• Research type

  Research Study

• Full title

  A Phase 3b, Randomized, Open-Label Study to Evaluate Switching from a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 60 Years

• IRAS ID

  188504

• Contact name

  Dr Laura Waters

• Contact email

  lwaters@nhs.net

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2015-002712-32

• Duration of Study in the UK

  1 years, 7 months, 31 days

• Research summary

  Combination HIV treatment has transformed the outlook for HIV patients. Starting treatment earlier will improve life expectancy and quality of life, although patients will potentially take treatment for decades. Longer treatment duration and an ageing HIV population require drug regimens that encourage patient adherence, prevention of drug resistance and minimal long-term toxicities. Most patients are treated with a combination of drugs, 2 nucleoside analogues plus one drug from another class. The preferred nucleoside analogue, Tenofovir disoproxil fumarate (TDF), for first-line HIV treatment, is associated with kidney toxicity and reduced bone mineral density (BMD - bone thinning). Tenofovir alafenamide fumarate (TAF) is an investigational version of tenofovir with similar effectiveness against HIV but less impact on kidney and bone.

  Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) is an all-in-one HIV treatment regimen (or fixed dose combination [FDC]) containing two nucleoside analogues (TAF and emtricitabine), a third drug from a different class (elvitegravir, an integrase inhibitor) and a booster (cobicistat increases blood levels of elvitegravir). The purpose of the study sponsored by Gilead Sciences, Inc is to evaluate switching to (E/C/F/TAF) FDC compared to continuing current antiretroviral therapy (ART) by measuring changes in spine/hip BMD in patients who are on successful HIV treatment. Eligible patients will have a suppressed virus on a combination of tenofovir, lamivudine or emtricitabine (both nucleoside analogues) and a 3rd drug.

  150 participants will take part at 30 sites globally. Participation will last 48 weeks, not including a screening period up to 42 days before the first study visit. Participants will visit the clinic at least 7 times and attend a follow-up visit.

  Participants will be selected by chance to receive one of the following:
  Treatment Group 1: receive E/C/F/TAF FDC once daily
  Treatment Group 2: remain on current TDF + FTC (emtricitabine) or 3TC (lamivudine) + third agent regimen

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  15/NW/0803

• Date of REC Opinion

  16 Nov 2015

• REC opinion

  Further Information Favourable Opinion