MK1439A in treatment naïve HIV1 infected subjects with NNRTI transmitt
Research type
Research Study
Full title
A Phase IIa Multicenter, Open-Label Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A in Treatment-Naïve HIV-1 Infected Subjects with Selected Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Transmitted Resistance Mutations.
IRAS ID
192214
Contact name
Dr Anton Pozniak
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-003616-20
Duration of Study in the UK
2 years, 8 months, 1 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.
However, while antiretroviral therapy can delay disease progression and death, as well as reduce the risk of HIV transmission, it does not cure the infection. As a result, lifelong treatment must be maintained, which can lead to the development of resistant virus.
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, open-label study to evaluate the safety and efficacy of MK-1439A once daily in subjects with selected transmitted resistance mutations (HIV resistance mutations to drugs that bind to HIV enzymes that are transmitted from infected individuals to uninfected individuals). Subjects to be enrolled will not have yet undergone any antiretroviral treatment.
Approximately 60 patients with one of the three most frequently transmitted resistance mutations will be enrolled into this study which will last approximately 102 weeks. The study will have 3 sites in the UK.
The study is funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
REC name
London - Riverside Research Ethics Committee
REC reference
15/LO/2008
Date of REC Opinion
17 Dec 2015
REC opinion
Favourable Opinion