Phase 3 study of NS5a inhibitor in patients coinfected with HIV & HCV
Research type
Research Study
Full title
Protocol AI444-043: A Phase 3, Open Label Study of Safety and Efficacy with BMS-790052 plus Peg-Interferon Alfa 2a and Ribavirin in Previously Untreated HCV Patients Coinfected with Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV)
IRAS ID
86975
Contact name
Mark Nelson
Sponsor organisation
Bristol Myers Squibb
Eudract number
2011-003067-30
Clinicaltrials.gov Identifier
Research summary
Title: A Phase 3 study of BMS 790052 plus Peg-Interferon Alfa 2a and Ribavirin in previously untreated Hepatitis C Virus (HCV) Patients Co infected with Human Immunodeficiency Virus (HIV) & Chronic Hepatitis C Virus. HIV/HCV co infected patients have higher levels of the HCV virus in their blood and more rapid progression of liver disease. Patients with HIV/HCV co-infection are also more susceptible to developing anemia which is common in HIV-infected patients. It has also been noted that HIV/HCV co infected patients may have more rapid progression to acquired immunodeficiency syndrome (AIDS) and AIDS related death. Therefore, as advances in antiretroviral therapy succeed in extending the life expectancy of HIV infected individuals, the burden of HCV related liver disease has emerged as a significant and increasing cause of morbidity and mortality in HIV positive patients. Treatment options for patients with Hepatitis C virus (HCV) infection are limited. Current therapies involve 24-48 weeks of treatment with Peg-Interferon Alfa 2a and Ribavirin. This combination has limited effectiveness in some patients and both have significant side effects. This highlights an unmet medical need for new therapeutics. This is an open label study so all patients will receive BMS 790052 plus Peg-Interferon Alfa 2a and Ribavirin. Participating patients will undergo: physical examinations, multiple blood tests, a heart function test and regular pregnancy tests (as Ribavirin can cause birth defects) A liver biopsy or fibroscan may also be required as part of the screening process. Patients will be regularly monitored and their treatment stopped if they do not respond or are unable to tolerate any side effects. Globally the study will begin in December 2011 and approximately 300 patients will participate worldwide. In the UK the study will begin in March 2012 and is due to end in October 2012. The study is funded by Bristol Myers Squibb.
REC name
London - Riverside Research Ethics Committee
REC reference
12/LO/0036
Date of REC Opinion
27 Jan 2012
REC opinion
Further Information Favourable Opinion