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for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:



This study will evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.

Official Title

A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection


Respiratory Syncytial Virus (RSV) Antiviral Lung Transplant


For people ages 18 years and up

Key Inclusion Criteria:

  • Received a LT (single or double) or heart/lung transplant > 90 days prior to screening
  • 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 study drug administration on Day 1/baseline
  • New onset or acute worsening of at least 1 of the following respiratory symptoms ≤ 7 days prior to study drug administration: nasal congestion, earache, runny nose, cough,sore throat, shortness of breath, or wheezing
  • An informed consent document signed and dated by the individual
  • A negative urine or serum pregnancy test for females of childbearing potential
  • Agreement from males and females of childbearing potential to use contraception
  • Ability and willingness to complete necessary study procedures

Key Exclusion Criteria:

Related to concomitant or previous medication use:

  • Use of the following lympholytic treatment: anti-thymocyte globulin (ATG), < 3 months;anti-lymphoblast globulin (ALG), < 3 months; muromonab-CD3 (OKT3), < 3 months;rituximab < 6 months; alemtuzumab < 9 months

Related to transplant history:

  • Recipient of any other organ transplant prior to screening, with the exception of a LT(single or double) or heart/lung transplant
  • Recipient of a hematopoietic cell transplant at any time
  • Presence of BOS Stage 3 at screening defined as a FEV1 of 50% or less of baseline

Related to medical condition at screening:

  • Respiratory failure requiring invasive mechanical ventilation
  • Evidence of shock requiring vasopressors
  • Known viral coinfection (including but not limited to influenza, metapneumovirus,human rhinovirus, parainfluenza, cytomegalovirus, or coronavirus) in the upper or lower respiratory tract ≤ 14 days prior to screening unless discussed with the medical monitor and deemed acceptable
  • Active systemic infection or infectious pneumonia of any etiology (ie, bacterial,viral [other than RSV] or fungal), including aspiration pneumonia, that is considered clinically significant by the investigator unless discussed with the medical monitor and deemed acceptable
  • Pregnant or lactating females
  • Evidence of recent and rapidly deteriorating lung function, occurring before the onset of the current viral respiratory infection

Related to allergies:

  • Known hypersensitivity or allergy to the study drug, its metabolites, or formulation excipients (microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc)
  • History of hypersensitivity, anaphylactic reaction, Stevens-Johnson Syndrome, or toxic epidermal necrolysis response to sulfa drugs

Related to laboratory values:

  • Clinically significant kidney dysfunction
  • Clinically significant liver function test abnormalities
  • Clinically significant elevations in total bilirubin (TB), as determined by the investigator

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


  • San Francisco, California, United States
  • Stanford, California, United States
  • Los Angeles, California, United States


in progress, not accepting new patients
Start Date
Completion Date
Gilead Sciences
Phase 2
Lead Scientist
Steven Hays
Study Type
Last Updated
April 1, 2017