Switch to MK-1439A from Ritonavir-boosted Protease Inhibitor regimen in HIV-1 infected subjects
Research type
Research Study
Full title
A Phase III Multicenter, Open-Label, Randomized Study to Evaluate a Switch to MK-1439A in HIV-1-Infected Subjects Virologically Suppressed on a Regimen of a Ritonavir-boosted Protease Inhibitor and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs).
IRAS ID
177219
Contact name
Andrew Ustianowski
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2014-005550-18
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
124,997, IND Number
Duration of Study in the UK
1 years, 8 months, 6 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; 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. It has the potential to be an ideal drug to switch to, due to favourable effectiveness and safety and anticipated lack of food requirements.
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, randomised, active-controlled study to evaluate a switch from a currently approved HIV treatment to MK-1439A in HIV-1 patients. Approximately 660 patients will be separated into two groups: a group that switch immediately to MK-1439A and a group that switch at study week 24. The study will compare the ability of MK-1439A to supress the virus for 48 weeks in HIV-1 subjects with the ability of the approved treatment to supress the virus for at least 24 weeks in HIV-1 subjects (who will have received their approved treatment for >48 weeks at the time of initial assessment).
The study will take place in UK hospitals.
The study is funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
15/NW/0505
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion