Reverse transcriptase inhibitors in antiretroviral therapy-naïve HIV-1

• Research type

  Research Study

• Full title

  A Phase IIb, multi-centre, randomised, double-blind, active-controlled trial comparing the neuropsychiatric adverse event profile of etravirine 400 mg q.d. versus efavirenz 600 mg q.d. in combination with 2 nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral therapy-naïve HIV-1 infected subjects.

• IRAS ID

  27006

• Contact name

  Mark Nelson

• Sponsor organisation

  Janssen-Cilag

• Eudract number

  2008-008655-42

• ISRCTN Number

  Unknown

• Research summary

  The Human Immunodeficiency Virus (HIV) attacks the body's immune system (defence system). The HIV virus can be spread through the exchange of certain bodilfluds. There is no cure, or vaccine, against HIV. Treatment involves using a combination of active antiretroviral drugs because HIV infection can develop resistance to a single treatment. Etravirine (ETR) which was previously known as TMC 125 is a drug used to treat HIV-1 infected patients. ETR treats HIV by disrupting the virus??s ability to multiply. Efavirenz (EFV) is another drug currently used for HIV treatment. Both drugs are known as non nucleoside reverse transcriptase (NNRTI). Janssen Cilag is sponsoring a study to compare and collect data on the neuropsychiatric (mental disorders attributable to diseases of the nervous system) adverse events profiles of ETR and EFV. Additionally this study will also look at overall safety and efficacy between the two treatment groups and etravirine concentrations in the blood of the patients will also be recorded. Approximately 150 HIV-1 infected patients who have never received antiretroviral (ARV) treatment will participate in the study across the European Union, Switzerland, Israel and Russia. The study is double-blind, active-controlled Phase IIb, which means that all patients will receive an active medicine (ETR or EFV) and a placebo (dummy pill). Patients will be randomly assigned (like tossing a coin) to one of the treatment groups below. Neither the doctor nor the patient will know which treatment has been administered to which patient. Treatment arm - 1: etravirine (ETR) 400 mg q.d (once daily dosing) plus placebo Treatment arm - 2: efavirenz (EFV) 600 mg q.d (once daily dosing) plus placebo Both ETR and EFV are always given in combination with other anti-HIV drugs. In this study, they are given in combination with two other approved drugs known as nucleoside/nucleotide reverse transcriptase inhibitors. These will be selected by the patient??s study doctor.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  09/H0206/36

• Date of REC Opinion

  18 Aug 2009

• REC opinion

  Further Information Favourable Opinion