A Phase 2 clinical trial investigating the anti-virus effects, kinetics and safety of GS-5806 in adults with RSV (Respiratory Syncytial Virus) infectio

Phase 1

• Conditions: Respiratory Syncytial Virus (RSV) Infection; MedDRA version: 18.0Level: LLTClassification code 10039247Term: RSV infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-002137-58-BE
• Lead Sponsor: Gilead Sciences Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-08
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

An informed consent document signed and dated by the subject or a legal guardian of the subject and Investigator or his/her designee
Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 5 of the protocol.
Male subjects must agree to use condoms during heterosexual intercourse and avoid sperm donation while enrolled in the study and for at least 90 days after administration of the last dose of study medication.
All subjects must refrain from blood donation while enrolled in the study and for 30 days after the last dose of IMP.
= 18 years of age at Screening
Willing to adhere to protocol specific requirements for contraception
Subject is a current inpatient
New onset or acute worsening of at least 1 upper or lower respiratory infectious symptom = 5 days prior to screening:
Upper respiratory tract symptoms: Nasal congestion, runny nose, sore throat, or earache
Lower respiratory tract symptoms: Cough, sputum production, wheezing, dyspnea, or chest tightness
Willingness to perform necessary study procedures and have available a working telephone or email
Documented to be RSV-positive at the current admission within 72 hours of Screening, or as evaluated at Screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

Related to concomitant or previous medication use:
- Use of any investigational medicinal product in the 28 days prior to screening, OR use of any investigational monoclonal antibody within 4 months or 5 half-lives of screening, whichever is longer, OR use of any investigational RSV vaccine ever
- Chronic use (> 28 days of use) of systemic immunosuppressive agents (i.e. alkylating agents, calcineurin inhibitors, immunophilin-binding but not a calcineurin inhibitor, antimetabolites, polyclonal antibodies, monoclonal antibodies) during the 28 days prior to Screening, or anticipated use during the 28 days following Screening
- Use of oral prednisone or other corticosteroid equivalent to:
- >20mg/day for > 14 days prior to screening is not permitted.
- >20mg/day for = 14 days, including corticosteroids received during current hospitalization (ie, bolus doses), is permitted.
- =20mg/day, regardless of duration, is permitted.
- Subjects taking a strong CYP inducer including but not limited to rifampin, St John’s wort, carbamazepine, and phenytoin
Related to medical history:
-Pregnant, breastfeeding, or lactating females
-Subjects requiring > 50% supplemental oxygen (while the subject is awake) at Screening
- Subjects with a CFS > 7 at Baseline
- Any clinically significant history of a bleeding disorder (as determined by the
investigator) at any time in the past or epistaxis (as determined by the investigator) within 30 days prior to screening
Known significant abnormality altering the anatomy of the nose or nasopharynx that in, the opinion of the investigator, will preclude obtaining adequate nasal swab sampling in either nasal passage
-Waiting for or recently (within the past 12 months) received a bone marrow, stem cell, or solid organ transplant, or who have received radiation or chemotherapy within 12 months prior to screening
- Known history of HIV/AIDS and a known CD4 count < 200 cells/µl
- History of severe dementia or Alzheimer’s disease
- History of drug and/or alcohol abuse that, in the opinion of the investigator, may prevent adherence to study activities
Related to medical condition:
- Influenza-positive as determined by local diagnostic test
- New onset of arrhythmia during current admission
-Use of mechanical ventilation during the current admission, not including noninvasive ventilation
- Clinically significant bacteremia or fungemia that has not been adequately treated prior to Screening, as determined by the investigator.
- Inadequate treatment of confirmed bacterial, fungal, or non-RSV pneumonia, as
determined by the investigator
- New cerebrovascular accident or stroke documented at the current admission
- Admission for trauma or emergent or planned surgeries
- Excessive nausea/vomiting at admission, as determined by the investigator, that precludes administration of an orally administered IMP
- Subjects with an unstable medical condition, as determined by the investigator, that preclude participation in the study
Related to allergies:
- Known allergy to components of the IMP (microcrystalline cellulose, mannitol,
croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide,
polyethylene glycol and talc).
- Documented history of acute (anaphylaxis) or delayed (Stevens-Johnson syndrome or epidermal necrolysis) allergy to sulfa drugs
Related to laboratory results at Screening:
-Serum creatinine clearance < 40 ml/min
-AST/ALT > 2x ULN
- Total bilirubin > 2x ULN
- Hemogl

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified