SECOND-LINE study

• Research type

  Research Study

• Full title

  A randomised open-label study comparing the safety and efficacy of ritonavir boosted lopinavir and 2-3N(t)RTI backbone versus ritonavir boosted lopinavir and raltegravir in participants virologically failing first-line NNRTI/2N(t)RTI therapy: the SECOND-LINE study.

• IRAS ID

  24966

• Contact name

  Brian Gazzard

• Sponsor organisation

  National Centre in HIV Epidemiology & Clinical Research

• Eudract number

  2009-012283-14

• Clinicaltrials.gov Identifier

  NCT00931463

• Research summary

  The study aims to research the use of a new antiretroviral drug called raltegravir as a key component of therapy following the failure of the first-line anti-HIV regimen (second-line HIV therapy). Current guidelines to treat HIV recommend the first types of drugs to be prescribed include drugs from 3 different classes. These classes are called nucleoside reverse transcriptase inhibitors (N(t)RTI), non-nucleoside reverse transcriptase inhibitors (NNRTI) and protease inhibitors (PI). Over time these combinations of antiretroviral drugs begin to lose effect in a proportion of people taking them. Eventually patients need to change to a different set of drugs in order to continue to keep the HIV under control and maintain their health. Guidelines recommend that once a person fails treatment with a drug combination with an NNRTI and 2 N(t)RTIs, they should switch to three drugs with a PI combined once again with 2 N(t)RTIs. However, the strength of this recommendation is poor because little research exists to show that this strategy works well. There is now a new anti-HIV drug called raltegravir which is a new class called the integrase strand-transfer inhibitor (InSTI) class. The evidence to date suggests that raltegravir is powerful and relatively free of unwanted side effects. The availability of this new drug means that we now have an opportunity to see how well it works in patients for whom the ??first-line? therapy is failing. The trial will enrol participants across a range of high-middle income sites in Australia, Asia, Latin America, Europe and low income sites in sub-Saharan Africa. The study will be conducted for 96 weeks and is expected to involve 550 eligible participants.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/28

• Date of REC Opinion

  24 May 2010

• REC opinion

  Further Information Favourable Opinion