A4001095 Maraviroc comparator study in antiretroviral naive HIV pts

• Research type

  Research Study

• Full title

  A multicenter, randomised, double-blind, comparative trial of Maraviroc + Darunavir/Ritonavir versus Emtricitabine/Tenofovir + Darunavir/Ritonavir for the treatment of antiretroviral-naive HIV-infected patients with CCR5-tropic HIV-1

• IRAS ID

  90983

• Contact name

  Stephen Kegg

• Sponsor organisation

  ViiV Healthcare UK Ltd

• Eudract number

  2010-021785-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main purpose of study A4001095 is to assess whether the drug Maraviroc given once a day in combination with darunavir/ritonavir is equally as effective as treatment with emtricitabine/tenofovir given once a day in combination with darunavir/ritonavir. Patients in the study will be starting therapy to treat HIV for the first time and will not have been treated with an antiretroviral drug before i.e. ART-naÇîve adults.The study is open to both male and female patients at least 18 years old and their involvement will last approximately 106 weeks (2 years 2 weeks) at dedicated research centres. Patients will need to visit the research site at least 14 times during the study for the following visits: Screening, Baseline Day 1, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, 96 or Early Termination.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  11/LO/1740

• Date of REC Opinion

  20 Mar 2012

• REC opinion

  Further Information Favourable Opinion