BMS AI468-038: Phase 2b HIV-1 Maturation Inhibitor study
Research type
Research Study
Full title
A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy, and Dose-response of BMS-955176, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults
IRAS ID
173342
Contact name
Chloe Orkin
Contact email
Eudract number
2013-005487-26
Clinicaltrials.gov Identifier
118,936, IND Number
Duration of Study in the UK
2 years, 4 months, 17 days
Research summary
There are now more people than ever living with HIV in the UK and up to 7,000 cases are diagnosed every year in the UK alone. It is vital that these patients receive treatment to minimise the level of HIV in the body, stop the weakening of the immune system, reduce HIV related diseases and prevent further transmission.
Almost all HIV-positive people in the UK are infected with a type of the virus called HIV-1. Despite the many advances in treatment for HIV-1, a significant proportion of patients experience treatment failure within 1 year for reasons such as drug resistance, side effects and complicated drug regimens so there is a need to research new products.
BMS-955176 is an investigational drug called a maturation inhibitor which is being developed by Bristol-Myers Squibb. This drug stops the production of new HIV1 viruses by blocking the activity of a protein in the virus. This mechanism of action is different to treatments already available.
Patients will take BMS955176 once daily in combination with other approved HIV medications. Early studies have demonstrated that it is generally well tolerated.
This study is a phase 2b dose finding study. Patients will be randomly assigned to receive one of three different doses of BMS-955176 in combination with existing HIV medications (tenofovir/emtricitabine). There will be a control group of patients who will receive a different existing HIV medication called Efavirenz in combination with tenofovir/emtricitabine.
The purpose of the research is to study BMS-955176 in combination tenofovir/emtricitabine. This information will help to select a dose of BMS-955176 for further research.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/0652
Date of REC Opinion
22 May 2015
REC opinion
Further Information Favourable Opinion