GSK1349572 + ABC/3TC v Atripla in HIV infected, treatment naive adults

• Research type

  Research Study

• Full title

  A Phase 3, randomised, double-blind study of the safety and efficacy of GSK1349572 plus abacavir/lamivudine fixed-dose combination therapy administered once daily compared to Atripla over 96 weeks in HIV-1 infected antiretroviral therapy naive adult subjects.

• IRAS ID

  63981

• Contact name

  Phillip Hay

• Sponsor organisation

  Viiv Healthcare

• Eudract number

  2010-020983-39

• ISRCTN Number

  Not Sent

• Research summary

  This is a randomised, double-blind study designed to demonstrate the safety and efficacy of GSK1349572 plus abacavir/lamivudine (ABC/3TC) versus Atripla (efavirenz/tenofovir/emtricitabine) over 96 weeks in HIV patients. GSK1349572 is an integrase inhibitor. Integrase inhibitors are a new class of antiretroviral drugs designed to block the action of the integrase viral enzyme. This enzyme works in several key steps in the human immunodeficiency virus (HIV) life cycle so it is an attractive target for HIV therapy. Atripla offers a full treatment regimen in a single tablet. The aim of this study is to obtain data to support a GSK1349572/ABC/3TC single tablet. This study will include approximately 800 subjects in about 15 countries globally and is sponsored by Viiv Healthcare. Eligible HIV-infected subjects will be aged 18 years or over. They should have a viral load of >/=1000c/ml and not previously have received integrase inhibitor treatment or any other antiretroviral treatment. Subjects will be assigned randomly to receive either GSK1349572 plus ABC/3TC or Atripla (approximately 400 subjects in each group) Subjects will participate in a Screening period of up to 28 days to ensure eligibility prior to assignment to study treatment. Subjects will then have visits every 4 weeks until week 16, followed by visits every 8 weeks until week 48 and every 12 weeks until week 96. Assessments will include height, weight, vital signs, ECG and blood samples. Subjects receiving Atripla will be discontinued from the study after their Week 96 visit, and will need to have made alternative arrangements to access antiretroviral medication. Subjects receiving GSK1349572 who complete 96 weeks of treatment will continue to have access to GSK1349572 until either it is locally approved or commercially available, until they no longer derive clinical benefit, until they meet a protocol-defined reason for discontinuation or until development of the compound is terminated.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  10/H0713/76

• Date of REC Opinion

  4 Jan 2011

• REC opinion

  Further Information Favourable Opinion