Trial Search Results

Presatovir in Hematopoietic Cell Transplant Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

One of the purposes of this study is to see if GS-5806 can decrease the amount of Respiratory Syncytial Virus (RSV) in autologous or allogeneic hematopoietic cell transplant (HCT) recipients. Another purpose of this study is to see how GS-5806 effects progression of your illness.

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


Key Inclusion Criteria:

   - Received an autologous or allogeneic HCT using any conditioning regimen

   - Evidence of new abnormalities on chest X-ray obtained < 48 hours prior to screening,
   determined to be consistent with LRTI by the local radiologist, relative to the most
   recent previous chest X-ray. If chest X-ray is not available, a chest X-ray must be
   obtained for screening.

   - Documented RSV in both the upper (eg, nasal swab, nasopharyngeal swab, nasal wash) and
   lower (eg, induced sputum, bronchoalveolar lavage, lung biopsy, but not spontaneous
   sputum) respiratory tract as determined by local testing (eg, polymerase chain
   reaction, direct fluorescence antibody, respiratory viral panel assay, or culture).
   All samples must have been collected ≤ 6 days prior to Day 1, or as determined at
   screening as per protocol.

   - An informed consent document signed and dated by the participant or a legal guardian
   of the participant and 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

Key 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

   - Use of a moderate or strong cytochrome P450 enzyme 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 study
   drug

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 conditions:

   - Requiring invasive mechanical ventilation at the time of randomization

   - Documented to be positive for other respiratory viruses (limited to influenza,
   parainfluenza, human rhinovirus, adenovirus, human metapneumovirus, or coronavirus),
   from the lower respiratory tract sample as determined by local testing

   - 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 individuals without an NG 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

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

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