Dose Response Naïve Efficacy Study

• Research type

  Research Study

• Full title

  A multicentre, randomised, double-blind, Phase 2b trial to determine the efficacy, tolerability and safety of 3 dose regimens of RDEA806 with open label efavirenz as active control in HIV 1-infected, antiretroviral naïve subjects

• IRAS ID

  7799

• Sponsor organisation

  Ardea Biosciences

• Eudract number

  2008-005113-21

• ISRCTN Number

  Not received

• 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 bodilfluds, such as blood, semen, and vaginafluds. There is no cure, or vaccine, for HIV infection. Treatment involves using a combination of medicines because HIV infection can quickly adapt and become resistant to one single treatment. Standard treatment generally involves the use of a combination of active antiretroviral drugs. Ardea Biosciences Inc. is sponsoring a study to evaluate the safety and efficacy of a new drug (RDEA806). The licensed anti-HIV drug, efavirenz will be used as a comparitor. Efavirenz is marketed in the UK under the name Sustiva©. 100 Adult HIV-1 infected adults who have had no previous treatment for their condition (treatment-naÇîve) will be randomly assigned to one of four treatment groups (25 in each group): 1 - RDEA806 600 mg: Given as 3 x 200 mg tablets with 2 matching placebo (similar looking drug with no medical effect) tablets. 2 - RDEA806 800 mg: Given as 4 x 200 mg tablets with 1 matching placebo tablet. 3 - RDEA806 1000 mg: Given as 5 x 200 mg tablets with no matching placebo. 4 - Efavirenz 600mg. Given as 3 x 200 mg capsules All patients will also receive Truvada© tablets (a combination of 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) once daily. Truvada is a licensed anti-HIV drug and is always given in combination with other anti-HIV drugs. The first 3 groups will be double blind meaning that neither the patient nor the study doctor will know the medication that is being given. Group 4 will be open label which will mean both the investigator and patient will be aware of the medication they have been given. This is a multicentre study with a treatment period of 48 weeks, and a follow-up period of 30 days.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  08/H0720/123

• Date of REC Opinion

  20 Nov 2008

• REC opinion

  Further Information Favourable Opinion