Respiratory Syncytial Virus (RSV) Infection of the upper respiratory tract. MedDRA version: 18.0 Level: LLT Classification code 10039247 Term: RSV infection System Organ Class: 100000004862
Conditions
Interventions
Product Name: GS-5806
Product Code: GS-5806
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not yet assigned
CAS Number: 1353625-73-6
Current Sponsor code: GS-5806
Other descriptive name:
Sponsors
Gilead Sciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 to 75 years of age 2. Received an autologous or allogeneic HCT using any conditioning regimen 3. Documented to be RSV-positive as determined by local testing (eg, PCR, DFA, RVP assay, or culture) using an upper respiratory tract sample collected = 6 days prior to Day 1 4. New onset of at least 1 of the following respiratory symptoms for = 7 days prior to Day 1: nasal congestion, runny nose, cough, or sore throat, or worsening of one of these chronic (associated with a previously existing diagnosis, eg, chronic rhinorrhea, seasonal allergies, chronic lung disease), respiratory symptoms = 7 days prior to Day 1 5. No evidence of new abnormalities consistent with LRTI on a chest X-ray relative to the most recent chest X-ray, as determined by the local radiologist. If a chest X-ray is not available or was not obtained during standard care =65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: Related to concomitant or previous medication use: 1. Use of non-marketed (according to region) investigational agents within 30 days, OR use of any monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whichever is longer, OR use of any investigational RSV vaccines after HCT. 2. Use of a moderate or strong cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St. John’s Wort, carbamazepine, and phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 1 week prior to the first dose of IMP Related to medical history: 3. Admitted to the hospital primarily for a lower respiratory tract disease of any cause as determined by the investigator 4. Pregnant, breastfeeding, or lactating females 5. Unable to tolerate nasal sampling required for this study, as determined by the investigator 6. Known history of HIV/AIDS with a CD4 count <200 cells/µL within the last month 7. History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities Related to medical condition at Screening: 8. Documented to be positive for other respiratory viruses (limited to influenza, parainfluenza, human rhinovirus, adenovirus, or human metapneumovirus, or coronavirus) within 7 days prior to the Screening visit, as determined by local testing (additional testing is not required) 9. Clinically significant bacteremia or fungemia within 7 days prior to Screening that has not been adequately treated, as determined by the investigator 10. Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to Screening that has not been adequately treated, as determined by the investigator 11. Excessive nausea/vomiting at Screening, as determined by the investigator, or an inability to swallow pills that precludes oral administration of the IMP (for subjects without an NG tube in place) 12. Any condition which, in the opinion of the investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints Related to allergies: 13. Known hypersensitivity or allergy to the IMP, its metabolites, or formulation excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc) 14. History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic epidermal necrolysis response to sulfa drugs Related to laboratory results: 15. Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method) 16. Clinically significant AST/ALT, as determined by the investigator 17. Clinically significant TB, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of GS-5806 on RSV viral load in RSV-positive autologous or allogeneic HCT recipients with acute URTI symptoms;Secondary Objective: - To evaluate the effect of GS-5806 on development of LRTC, progression to respiratory faliure, and all-cause mortality - To evaluate the PK, safety, and tolerability of GS-5806;Primary end point(s): Time-weighted average change in nasal RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 as measured by RT-qPCR;Timepoint(s) of evaluation of this end point: Day 1 to day 9 (daily measure) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Proportion of subjects who develop a LRTC through Day 28, defined as one of the below, as determined by the adjudication committee: - Primary RSV LRTI - Secondary bacterial LRTI - Lower respiratory tract infection due to unusual pathogens - Lower respiratory tract infection, noninfectious or of unknown etiology Number of supplemental O2 free days through Day 28 Proportion of subjects developing respiratory failure (of any cause) requiring mechanical ventilation (invasive or noninvasive) through Day 28 Proportion of all-cause mortality through Day 28;Timepoint(s) of evaluation of this end point: Day 28. | — |
Countries
Australia, Austria, Brazil, Canada, France, Germany, Hong Kong, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed