MK-1439A versus ATRIPLA in treatment-naïve HIV-1 infected subjects
Research type
Research Study
Full title
A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA Once-Daily in Treatment-Naive HIV-1 Infected Subjects
IRAS ID
177217
Contact name
Chloe Orkin
Contact email
Sponsor organisation
Merck Sharp and Dohme Ltd
Eudract number
2014-003382-17
Clinicaltrials.gov Identifier
124997, IND Number
Duration of Study in the UK
2 years, 7 months, 24 days
Research summary
Human immunodeficiency virus type 1 (HIV-1) is the virus that causes Acquired Immune Deficiency 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.
MK-1439A is an antiretroviral therapy developed by Merck for the treatment of HIV-1 infection in HIV infected subjects. MK-1439A inhibits the HIV virus from replicating, which can decrease the viral load, help suppress the infection and improve the functioning of the immune system.
This study will recruit HIV-1 infected, antiretroviral treatment-naïve (have not received antiretroviral therapy) patients.
This is a multicenter, double-blind, randomized, active-controlled trial to evaluate the safety and efficacy of MK-1439A compared with ATRIPLA™ (an antiretroviral drug currently licensed). MK-1439A has a favourable adverse event (side effects) profile compared to ATRIPLA™.
Patients will visit the clinic about 13 times over a 2 year period. Patients will be monitored regularly for their HIV-1 infection and safety and tolerability according to usual standards practice.
About 680 patients will take part in this study.
The study will take place at 9 UK hospitals.
The study is funded by Merck Sharp & Dohme Limited.
REC name
London - Westminster Research Ethics Committee
REC reference
15/LO/0881
Date of REC Opinion
10 Jul 2015
REC opinion
Further Information Favourable Opinion