Trial Search Results

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus Infection of the Upper Respiratory Tract

One of the purposes of this study is to see if GS-5806 can decrease the amount of RSV (Respiratory Syncytial Virus) in patients who have received autologous or allogeneic hematopoietic cell transplant (HCT). Another purpose is to see whether GS-5806 has an effect on how often or how quickly the RSV infection spreads from the upper airway (nose and throat) to the lungs. Another purpose of the study is to see if GS-5806 helps people with RSV feel better faster.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Gilead Sciences

Stanford Investigator(s):

Intervention(s):

  • Drug: Presatovir
  • Drug: Placebo

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Received an autologous or allogeneic HCT using any conditioning regimen

   - Documented to be RSV-positive as determined by local testing (eg, polymerase chain
   reaction, direct fluorescence antibody, respiratory viral panel assay, or culture)
   using an upper respiratory tract sample collected ≤ 6 days prior to Day 1

   - 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

   - No evidence of new abnormalities consistent with lower respiratory tract infection
   (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 < 48 hours prior to screening, a chest X-ray must be obtained for
   screening

   - O2 saturation ≥ 92% on room air

   - An informed consent document signed and dated by the participant or a legal guardian
   of the participant and the investigator or his/her designee

   - A negative urine or serum pregnancy test is required for female participants (unless
   surgically sterile or greater than two years post-menopausal)

   - Male and female participants of childbearing potential must agree to contraceptive
   requirements as described in the study protocol

   - Willingness to complete necessary study procedures and have available a working
   telephone or email

Exclusion Criteria:

Related to concomitant or previous medication use:

   - 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

Related to medical history:

   - Pregnant, breastfeeding, or lactating females

   - Unable to tolerate nasal sampling required for this study, as determined by the
   investigator

   - Known history of HIV/AIDS with a CD4 count <200 cells/μL within the last month

   - 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:

   - 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)

   - Clinically significant bacteremia or fungemia within 7 days prior to screening that
   has not been adequately treated, as determined by the investigator

   - Clinically significant bacterial, fungal, or viral pneumonia within 2 weeks prior to
   screening that has not been adequately treated, as determined by the investigator

   - Excessive nausea/vomiting at screening, as determined by the investigator, or an
   inability to swallow pills that precludes oral administration of the investigational
   medical product (for participants without an nasogastric tube in place)

   - 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 laboratory results:

   - Creatinine clearance < 30 mL/min (calculated using the Cockcroft-Gault method)

   - Clinically significant aspartate aminotransferase/alanine aminotransferase, as
   determined by the investigator

   - Clinically significant total bilirubin, as determined by the investigator

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting