A Phase IIb Study of GS-5806 in Stem Cell Transplant Recipients with RSV Infection of the Upper Airways

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 Upper Respiratory Tract

Purpose

Respiratory syncytial virus (RSV) in healthy people normally causes cold-like symptoms. But RSV infection in people with weakened immunity, such as those who've had a stem cell transplant, can cause inflammation of the small airways and pneumonia, and sometimes requires hospitalization and intensive treatment. There is no approved medication for RSV infection in adults.

GS-5806 is an investigational drug designed to inhibit the ability of RSV to reproduce. In this study, researchers are determining the best dose of GS-5806 to use in adult stem cell transplant recipients with RSV infection and to see how they respond to this treatment. Patients will be randomly assigned to receive either GS-5806 or a placebo (inactive drug). GS-5806 is taken orally (by mouth) or given through a nasogastric tube.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must be stem cell transplant recipients with RSV that is causing symptoms.
  • This study is for people age 18 to 75.

For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Protocol

15-260

Phase

II

Investigator

Locations