PROTEAse inhibitor in HIV-1 patients

• Research type

  Research Study

• Full title

  PROTEAse inhibitor (DRV/rtv) in mono- or triple therapy in suppressed HIV-1 infected subjects.

• IRAS ID

  83844

• Contact name

  Mark Nelson

• Sponsor organisation

  Janssen Cilag International N.V.

• Eudract number

  2011-001635-23

• Clinicaltrials.gov Identifier

  Unknown

• Research summary

  Human Immunodefiency Virus (HIV) is a virus that causes acquired immunodeficiency syndrome (AIDS); a condition in humans where the ??defence?? or immune system fails, allowing infections and cancers to thrive. HIV infection is transferred by bodilfluds during eg. unsafe sex, used needles, breast milk and transmission from an infected mother to her baby at birth. There is no cure or vaccine for HIV infection. Treatment involves using a combination of drugs, also known as anti-retrovirals (ARVs). ARVs are divided in different classes eg. nucleoside/tide analogue reverse transcriptase inhibitors (N[t]RTI) and protease inhibitors (PIs). Highly active antiretroviral therapy (also known as HAART) is a combination of medications from different classes. Darunavir(DRV, PREZISTA©) is a PI and has been approved to be used with ritonavir (rtv, NORVIR© - also a PI) for the treatment of HIV infection.Janssen Cilag International N.V. is sponsoring this study to collect information on ritonavir-boosted darunavir. Patients who have been taking HAART medication will be assigned to either receive darunavir/ritonavir as single therapy (also called monotherapy) or in combination with 2 N[t]RTIs (also called triple therapy as three therapies are used). The purpose of this study is to test whether darunavir/ritonavir is as effective as the triple therapy. The study will look how safe and tolerable treatments are between the 2 treatment groups, and will also compare patients?? brain function. Patients will be allocated to the treatment groups at random, therefore like tossing a coin. Neither the patient nor the doctor can choose which group the patient is allocated to but they will know which treatment the patient is receiving. This is a multicentre study which will take place across Europe and Israel. It is anticipated that approximately 260 patients will be recruited.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  11/LO/1498

• Date of REC Opinion

  29 Nov 2011

• REC opinion

  Further Information Favourable Opinion