Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection

• Status: Completed
• Trial end date: 2017-04-12
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the effects of presatovir on respiratory syncytial virus (RSV) viral load in RSV-positive adults who have been hospitalized with acute respiratory infectious symptoms.

Participants will receive 1 dose of presatovir on Day 1 and followed for 27 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• Current inpatient

• New onset of acute respiratory infectious symptoms, or acute worsening of chronic symptoms related to ongoing respiratory disease for ≤ 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

• Documented to be RSV-positive at the current admission within 72 hours of screening, or as evaluated at screening

Key Exclusion Criteria:

• Related to concomitant or previous medication use:

• Use of oral prednisone or other corticosteroid equivalent to:

• > 20 mg/day for > 14 days prior to screening is not permitted.

• > 20 mg/day for ≤ 14 days, including corticosteroids received during current hospitalization (ie, bolus doses), is permitted.

• ≤ 20 mg/day, regardless of duration, is permitted.

• Individuals taking a moderate or strong cytochrome P450 enzyme (CYP) inducer including but not limited to rifampin, St John's Wort, carbamazepine, phenytoin, efavirenz, bosentan, etracirine, modafinil, and nafcillin within 2 weeks prior to the first dose of study drug

• Related to medical history:

• Pregnant, breastfeeding, or lactating females

• Individuals requiring > 50% supplemental oxygen (while the individual is awake) at screening

• Individuals with a Clinical Frailty Scale (CFS) > 7 at Baseline

• 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

• Individuals with HIV/AIDS and a known CD4 count < 200 cells/uL

• 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 at screening:

• Influenza-positive as determined by local diagnostic test

• Known Middle East Respiratory Syndrome coronavirus (MERS-CoV) infection or known coinfection with other coronavirus

• 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

• Excessive nausea/vomiting at admission, as determined by the investigator, that precludes administration of an orally administered study drug

• Related to allergies:

• Known allergy to components of the study drug (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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.