GS-5806 in HCT Recipients with Lower Respiratory Tract Infection
Research type
Research Study
Full title
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients with Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract
IRAS ID
161837
Contact name
Antonio Pagliuca
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-002475-29
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Respiratory Syncytial Virus (RSV) causes mild, cold-like symptoms in adults and older healthy children. Symptoms are fever, stuffy nose, cough, and trouble breathing. It can cause serious problems in young babies and those with other health problems, including pneumonia and severe breathing problems. There is an annual epidemic during the winter months / rainy season. Natural infection with RSV induces protective immunity which wanes over time and thus people can be infected multiple times.
Hematopoietic cell transplantation (HCT) recipients undergo radiation or chemotherapy before the transplantation with which the recipient's immune system is destroyed. Respiratory virus infections are common in HCT recipients and are associated with high mortality after HCT. RSV is one of the most common viruses that cause progression from upper to lower respiratory tract disease in HCT recipients and mortality rates are between 25%–45% within 30 days after progression to pneumonia.
Treatment is limited to supportive care including oxygen therapy and C-PAP which is a machine to help with breathing during sleep. The only approved antiviral therapy for RSV, ribavarin, is approved for use in children as well as HCT recipients, but is rarely used in clinical practice due to its limited efficacy. In addition it is uncomfortable for patients and therefore poorly tolerated. More aggressive therapy, including immunotherapy, or antiviral and immunotherapy with or without corticosteroids may be warranted for immunocompromised patients. There is a significant unmet medical need for a safe, convenient, and effective treatment for RSV infection.
The study is designed to evaluate the safety, tolerability and effectiveness of GS-5806 among HCT patients with an RSV related upper respiratory tract infection. GS-5806 has selective anti-RSV activity. Data from this study and data from other studies will be used to support further clinical development of GS-5806 in paediatric and adult patients infected with RSV.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
14/NE/1204
Date of REC Opinion
10 Apr 2015
REC opinion
Further Information Favourable Opinion