Harvoni for Acute GT 1 or 4 HCV and Chronic HIV-1 Co-Infection
Research type
Research Study
Full title
Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed-Dose Combination (FDC) for 6 Weeks in Subjects with Acute Genotype 1 or 4 Hepatitis C Virus (HCV) and Chronic Human Immunodeficiency Virus (HIV)-1 Co-Infection
IRAS ID
173357
Contact name
Mark Nelson
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-004812-12
Duration of Study in the UK
0 years, 9 months, 22 days
Research summary
This study will examine how safe and effective the medicine Harvoni® is at treating a person’s Hepatitis C disease when that person is also suffering from Human Immunodeficiency Virus (HIV).
Hepatitis C is a disease caused by the hepatitis C virus (HCV) that primarily affects the liver. A virus is a small organism that attaches itself to healthy cells and forces them to make more of the virus. In HCV, this causes the infected liver cells to become inflamed, which over time causes liver scarring – called fibrosis – and can lead to permanent liver damage, called cirrhosis. If the cirrhosis is severe, a liver transplant may be required.
A virus can exist in different forms based on its genetic make-up (its genes). There are six main forms (called genotypes) of HCV and two genotypes of HIV virus. This study is open to participants infected with HCV genotype 1 and 4 that are also infected with genotype 1 HIV. About 25 male and female participants aged 18 or over, will be enrolled in this study from Germany and the UK.
Harvoni® is a combination of two medicines for the treatment of hepatitis C, Ledipasvir (LDV) and Sofosbuvir (SOF) that have been combined into a single tablet. It is licensed in the UK for the treatment of certain HCV genotypes, but it has not been tested in individuals that are suffering from HCV with HIV co-infection.
Eligible participants will receive the study medicine, Harvoni® tablets, to be taken once daily for 6 weeks. Participants will come to the clinic 5 times over the 6 week period and will undergo tests to monitor their health. After completing the treatment, participants will need to return to the clinic for 2 follow-up visits to monitor their health.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0438
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion