MK-8504 Single Dose Study in HIV-1 Infected Patients
Research type
Research Study
Full title
A Single-Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Anti-Retroviral Activity of MK-8504 Monotherapy in Anti-Retroviral Therapy (ART)-Naïve, HIV-1 Infected Patients
IRAS ID
228993
Contact name
Marta Boffito
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-000998-37
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Human immunodeficiency virus (HIV) causes acquired immunodeficiency syndrome (AIDS). HIV infection leads to a depletion of immune cells, making the host increasingly vulnerable to disease. Currently, HIV infected patients have been successfully treated with anti-retroviral (ARV) therapy, which prevents the growth of the virus, and allows patients to live near-normal lives.
However, while ARVs can delay disease progression and death and reduce the risk of HIV transmission, it does not cure the infection. Lifelong treatment must be maintained, which can potentially lead to the development of resistant virus. Additionally, many ARVs are associated with kidney and bone toxicity and there is a clear need for better treatments in this respect. Increased tolerability and easier administration are expected to improve a patient’s commitment to continue with long-term treatment.
The ARV to be tested in this study, MK-8504, prevents the HIV from replicating, which can decrease the number of virus particles in the blood (viral load), help suppress the infection and improve the functioning of the immune system. It is anticipated that MK-8504 may have an improved side-effects profile compared to other ARV treatments which could reduce the possibility of non-compliance due to side effects.
This is a Phase 1, open-label study, lasting approximately 7 months, which will evaluate the safety, tolerability and effectiveness of MK-8504 in HIV infected patients who have not yet undergone anti-retroviral treatment.
Approximately 18-24 patients will be enrolled into this study and will receive a single administration of one of four doses of MK-8504.
The study is funded by Merck Sharp & Dohme Limited and will take place at a single study centre in the UK.REC name
London - City & East Research Ethics Committee
REC reference
17/LO/1065
Date of REC Opinion
14 Aug 2017
REC opinion
Further Information Favourable Opinion