Switch HIV infected subjects with CNS toxicity from Atripla to MK1439A

• Research type

  Research Study

• Full title

  Phase IIb, Double-Blinded, Multicenter, Randomized Study to Assess the Effect on Central Nervous System (CNS) Toxicity of Switching from ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Subjects

• IRAS ID

  193977

• Contact name

  Mark Nelson

• Contact email

  mark.nelson@chelwest.nhs.uk

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Eudract number

  2015-003617-18

• Duration of Study in the UK

  1 years, 3 months, 3 days

• Research summary

  Human immunodeficiency virus (HIV) is the virus which causes acquired immunodeficiency syndrome (AIDS). The HIV infection leads to a depletion of immune cells (CD4+ cells); this makes the host increasingly vulnerable to pathogens and diseases. HIV infected patients have been successfully treated with antiretroviral therapy. The aim of antiretroviral therapy is to suppress HIV to an undetectable level, so that immune function is preserved or restored.

  Patients are increasingly switching HIV treatments with increased concerns for the risks of long term toxicity. The drug to be tested in this study, MK-1439A, inhibits the HIV virus from replicating, which can decrease the viral load and help suppress the infection and improve the functioning of the immune system.
  MK-1439A is a single-tablet treatment which contains a full daily HIV treatment of MK-1439, and two other approved HIV drugs in one tablet. This simplified treatment could reduce the possibility of noncompliance if the alternative treatment is difficult to adhere to.

  This is a multicentre, double-blind, randomised, active-controlled study to evaluate a switch from a currently approved HIV treatment, Atripla, to MK-1439A in HIV-1 patients with CNS toxicity. Approximately 106 patients will be separated into two groups: a group that switch immediately to MK-1439A (Immediate Switch Group) and a group that switch at study week 12 (Deferred Switch Group). The study will look at the effect of switching to MK-1439A on the frequency of side effects experienced by patients compared with the frequency of side effects experienced by the group remaining on the approved treatment.

  The study will take place at 7 UK sites.

  The study is funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

  Lay summary of study results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT02652260%253Fterm%253D1439A-028%2526rank%253D1%2523study-overview%2FNBTI%2Feg_8AQ%2FAQ%2Ff4f434c1-2274-4f43-b383-deb2b87cb419%2F1%2FWxzfFT3ScL%23study-overview&data=05%7C02%7Cfulham.rec%40hra.nhs.uk%7C5c0fac0b833842be457f08dd65705444%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638778255321452758%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=n61C2jr8E5LRhDKhkPwQ3S0Cyt%2BmlJjKfyYTuG66n3Y%3D&reserved=0
  

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  15/LO/2121

• Date of REC Opinion

  26 Jan 2016

• REC opinion

  Further Information Favourable Opinion