HARNESS

• Research type

  Research Study

• Full title

  An Open-Label, Randomized Study Evaluating a Switch from a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors plus any Third Agent to either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on their Present Treatment Regimen (the HARNESS study).

• IRAS ID

  81736

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2009-017032-41

• Clinicaltrials.gov Identifier

  NCT01332227

• Research summary

  This is an open label study where HIV infected patients who are stable on a regimen which consists of 2 NRTI any 3rd agent but who are experiencing side effects with this regimen, will be switched to a regimen consisting of Atazanavir and Heat Stable Ritonavir plus Raltegravir (experimental arm) or Atazanavir and Heat Stable Ritonavir plus Tenofovir/Emtricitabine (standard arm). The study is looking to confirm that patients who are switched to the experimental arm remain stable and have a reduction in side effects.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/1081

• Date of REC Opinion

  18 Jul 2011

• REC opinion

  Favourable Opinion