Phase 3 study in treatment-naïve HIV-1 infected subjects
Research type
Research Study
Full title
A Phase 3 Multicentre, Double-Blind, Randomised, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily plus Ritonavir 100 mg Once Daily, Each in Combination with TRUVADA TM or EPZICO TM/KIVEXA TM in Treatment-Naive HIV-1 Infected Subjects
IRAS ID
164748
Contact name
Mohammed Haq
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2014-001127-69
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
112,796, IND Number
Duration of Study in the UK
2 years, 10 months, 18 days
Research summary
HIV infected patients have been successfully treated with a combination of antiretroviral therapies or highly active antiretroviral therapy (HAART). The goal is to suppress HIV to undetectable levels in the body so that immune function is preserved or restored. There are concerns about long term side effects of some of the widely used drugs and viruses which are not treated well enough by the current drugs will remain a long term threat so further new combination treatments are needed.
MSD Ltd, are investigating a new medicine called Doravirine. Doravirine is a strong inhibitor of HIV-1 replication and is active against the virus with one daily dosing. Patients diagnosed with HIV-1 who have not previously been treated for HIV-1 will be randomly assigned to receive either Doravirine or darunavir/ritonavir (current medicines prescribed for the treatment of HIV), each in combination with TRUVADA or EPZICOM/KIVEXA (current medicines prescribed for treatment of HIV). Neither the doctor nor patient will know the treatment they are assigned (double blinded). Patients will still receive a treatment (TRUVADA or EPZICOM/KIVEXA) even if they are randomised to Placebo.
Approximately 680 participants will be recruited across 13 countries. The duration of treatment for a given patient is 96 weeks. Patients who meet the criteria will return to the site within 45 days upon screening for getting randomised and to start treatment. During the study patients have to return for 12 regularly study visits for safety laboratory assessments and for being dispensed new study medication. 14 days after treatment end a final follow up visit with laboratory safety assessment will be conducted.
Blood samples to support the evaluation of population pharmacokinetics (PK) (the amount of study drug in the participants’ blood) will be collected from all participants at randomisation and Weeks 4, 8, 24 and 48.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0075
Date of REC Opinion
25 Feb 2015
REC opinion
Further Information Favourable Opinion