Phase 4 Renal Study in Patients with Treatment-Naive HIV-1

• Research type

  Research Study

• Full title

  A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF or Efavirenz /Emtricitabine/Tenofovir DF) compared to Ritonavir boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR =70 mL/min

• IRAS ID

  158109

• Contact name

  Graeme Moyle

• Contact email

  Graeme.Moyle@chelwest.nhs.uk

• Sponsor organisation

  Gilead Sciences, Inc.

• Eudract number

  2014-002095-93

• Research summary

  The treatment of HIV-1 infection requires the combination of several medications in order to decrease the amount of virus in the body, improve immune function and delay the progression of the disease. Stribild® (STB) is a single tablet regimen that contains four medications (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumurate) and has been developed by Gilead Sciences, Inc.

  STB was first approved for the treatment of HIV-1 infection in adults in the EU on 24 May 2013. This proposed study is to be conducted to fulfil an EU post-approval commitment to further investigate the effect of STB on the function of the kidneys in HIV-1 infected patients.

  There are 4 treatment groups in this study; each one containing approved HIV-1 drugs. Participants, who have not started any HIV-1 treatment, will be randomly selected by chance to start in one of these groups. Each treatment group is different so that it makes it easier to see the effects that each group has on the kidneys in comparison to the others:

  A. Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumurate (EVG/COBI/FTC/TDF) [STB]
  B. Atazanavir boosted by ritonavir (ATV/r) plus FTC/TDF
  C. Efavirenz/emtricitabine/tenofovir disoproxil fumurate (EFV/FTC/TDF)
  D. Atazanavir boosted by ritonavir (ATV/r) plus ABC/3TC

  64 participants from approximately 24 sites in Europe will be recruited into this study and approximately half of these participants will be recruited in the UK.

  Taking part in this study will last about 28 weeks including the screening visit. During this time, participants will be required to visit the clinic at least 8 times where the following procedures will be performed: physical examination, vital signs, ECG (heart monitoring), blood sampling, urine sampling, kidney function tests, and pharmacokinetic (what the body does to the drug) and pharmacodynamic (the effects of the drug on the body) sample collection.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  14/LO/1513

• Date of REC Opinion

  24 Sep 2014

• REC opinion

  Further Information Favourable Opinion