respiratory infection RSV infection
Conditions
Interventions
Subjects will be randomized in a 2:1 ratio to receive presatovir administered
as a 200-mg dose on Day 1/Baseline, followed by a 100 mg dose daily on Days 2
through 14, or placebo-to-match (PTM) once
GS 5806
lung transplant
RSV infection
Sponsors
Gilead Sciences
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Males and females * 18 years of age who have received a LT (single or double) or heart/lung transplant > 90 days prior to Screening 2) Confirmed to be RSV-positive by local polymerase chain reaction (PCR) testing (starting from when the upper or lower respiratory tract sample is obtained) * 7 days prior to IMP administration on Day 1/Baseline 3) New onset or acute worsening, if the symptom is chronic, of at least 1 of the following respiratory symptoms * 7 days prior to IMP administration on Day 1/Baseline: nasal congestion, earache, runny nose, cough, sore throat, shortness of breath, or wheezing 4) An informed consent document signed and dated by the subject 5) A negative local urine or serum pregnancy test for female subjects of childbearing potential at Screening within 1 day prior to IMP administration. When available, existing local pregnancy test results obtained prior to Screening may be used, provided the testing was completed within 1 day prior to IMP administration. 6) Agreement from male and female subjects of childbearing potential who engage in heterosexual intercourse to use protocol specified method(s) of contraception as described in Appendix 6 7) Ability and willingness to complete necessary study procedures
Exclusion criteria
Exclusion criteria: 1) Use of any non-marketed (according to region) investigational agents within 30 days, OR use of any investigational monoclonal anti-RSV antibodies within 4 months or 5 half-lives of Screening, whichever is longer, OR use of any prior investigational RSV vaccines 2) Use of a strong or moderate cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St. John*s Wort, carbamazepine, phenytoin, efavirenz, bosentan, etravirine, modafinil, and nafcillin, within 2 weeks prior to the first dose of IMP 3) Use of any of the following lympholytic treatment within the stated time frame: anti-thymocyte globulin (ATG), 5 times the ULN obtain
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The co-primary efficacy endpoints are * Time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) as measured in nasal samples by RT-qPCR among subjects in the FAS * Time-weighted average change in log10 viral load from Day 1/Baseline through Day 7 (DAVG7) in a subset of FAS subjects whose duration of RSV symptoms prior to the first dose of study medication is * median | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are: * Time-weighted average change in FLU-PRO score from Day 1/Baseline through Day 7 * Percent change from study baseline in FEV1% predicted value at Day 28/End of Study | — |
Countries
The Netherlands
Outcome results
None listed