GSK1349572 v Raltegravir in HIV infected, treatment experienced adults

• Research type

  Research Study

• Full title

  A Phase III Randomized, Double-blind Study of the Safety and Efficacy of GSK1349572 50 mg Once Daily Versus Raltegravir 400 mg Twice Daily, Both Administered with an Investigator-selected Background Regimen Over 48 Weeks in HIV-1 Infected, Integrase Inhibitor-Naïve, Antiretroviral Therapy-Experienced Adults.

• IRAS ID

  61234

• Contact name

  Julie Fox

• Sponsor organisation

  Viiv Healthcare

• Eudract number

  2009-018001-51

• ISRCTN Number

  Not Known

• Research summary

  Research Summary
  This is a randomised, double-blind, multicentre study designed to demonstrate the non-inferior antiviral activity of GSK1349572 50 mg once daily versus raltegravir (RAL) 400 mg twice daily over 48 weeks. GSK1349572 and Raltegravir are integrase inhibitors. Integrase inhibitors (INIs) 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 HIV life cycle so it is an attractive target for HIV therapy. This study will be conducted in approximately 688 subjects in about 20 countries globally and is being sponsored by Viiv Healthcare. Subjects will be randomised to receive either GSK1349572 50 mg once daily (approximately 344 subjects) or 400 mg RAL twice daily (approximately 344 subjects), each added to an investigator selected background regimen. Eligible subjects will be HIV-1 infected and of 18 years of age or over. They should have a viral load of >400c/ml, show resistance to 2 or more classes of antiretroviral agents and be integrase inhibitor naïve. Subjects randomized to the RAL arm will receive RAL through to their Week 48 visit, after which they will be discontinued from the study and will need to have made alternative arrangements to access antiretroviral medication. Subjects randomised to GSK1349572 who complete 48 weeks of treatment will continue to have access to GSK1349572 until either it is locally approved and 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. Subjects will participate in a Screening period of up to 35 days to ensure eligibility prior to randomization. Subjects will then have visits every 4 weeks until week 16, followed by visits every 12 weeks. Assessments will include height, weight, vital signs, ECG and blood samples.

  Summary of Results
  Plain Language Summaries were not required when we achieved primary endpoint (Week 48).

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/67

• Date of REC Opinion

  24 Nov 2010

• REC opinion

  Further Information Favourable Opinion