Atripla toxicity switch to raltegravir study

• Research type

  Research Study

• Full title

  A phase III, open-label, single centre, single-arm, pilot study to assess the feasibility of switching, individuals receiving efavirenz with continuing Central Nervous System (CNS) toxicity, to raltegravir

• IRAS ID

  47477

• Contact name

  Mark Nelson

• Sponsor organisation

  St Stephen's AIDS Trust

• Eudract number

  2010-018878-21

• ISRCTN Number

  Not Known

• Research summary

  The Human Immunodeficiency Virus (HIV) attacks the body's immune system, which provides a natural defence system against disease and infection. The HIV virus can be spread through the exchange of bodily fluids, such as blood, semen, and vaginal fluids. There is no cure, or vaccine, for HIV infection. The introduction of highly active antiretroviral therapy has revolutionised the treatment of HIV disease, leading to marked reductions in HIV related diseases and deaths. Efavirenz (as part of the combined pill Atripla) is a drug used to treat HIV; sometimes this gives patients central nervous system (CNS) side effects such as difficulty sleeping and bad dreams. This study aims to investigate the effect of switching from efavirenz to another drug used to treat HIV, raltegravir (with Truvada). Raltegravir is a licensed drug for the treatment of HIV which has shown fewer side effects when compared to efavirenz in two other clinical trials, where patients were starting HIV treatment for the first time. This study will also investigate the safety (in terms of other side effects and routine bloods used as standard to monitor patients treatment) and monitor effectiveness and patients' viral load (the amount of the HIV virus in the blood) when patients switch from Atripla to Truvada/raltegravir. Up to 40 HIV infected patients with an undetectable viral load on Atripla with CNS side effects will participate in this study. After screening participants will continue to take their Atripla until the baseline visit. At the baseline visit participants will switch from Atripla to Truvada/raltegravir. Participants will attend the clinic 4 weeks and 12 weeks after switching. This is an open label, singlearm, single centre study.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  10/H0706/37

• Date of REC Opinion

  16 Aug 2010

• REC opinion

  Further Information Favourable Opinion