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Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV) (Challenge)

This study is currently recruiting participants.
Verified January 2013 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01756482
First received: December 20, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  Purpose

This study is to evaluate the antiviral effect of GS-5806 in healthy adults infected with a strain of Respiratory Syncytial Virus.


Condition Intervention Phase
Respiratory Syncytial Virus Infections
 Drug: GS-5806
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Phase 2a Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV-A Memphis 37b Strain)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change in viral load measurements. [ Time Frame: Post initial dose of GS-5806/placebo to Day 12 ] [ Designated as safety issue: Yes ]
    Area under the curve for viral load as measured by qRT-PCR assay from the first viral load measurement post initial dose of GS-5806 or placebo through day 12.


Secondary Outcome Measures:
  • Change of baseline symptoms [ Time Frame: Innoculation through Day 12 ] [ Designated as safety issue: Yes ]
    Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12


Estimated Enrollment: 140
Study Start Date: November 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-5806
GS-5806, powder for oral solution
 Drug: GS-5806
GS-5806, powder for oral solution
Placebo Comparator: Sugar powder for oral solution in juice
Sugar powder for oral solution
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female
  • Between 18 to 45 years old
  • Body Mass Index of 18 to 33 kg/m2

Exclusion Criteria:

  • Acute or chronic medical illness
  • Positive for Human Immunodeficiency Virus, Hepatitis B or C
  • Nose or nasopharynx abnormalities
  • Abnormal lung function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756482

Contacts
Contact: Jason Chien, MD, MS 206-256-4926 jason.chien@gilead.com
Contact: Seth Toback, MD 206) 832-2110 seth.toback@gilead.com

Locations
United Kingdom
Retroscreen Virology Recruiting
London, United Kingdom, E12AX
Contact: Adeyemi Adeyi, MD     02077561374     a.adeyi@retroscreen.com    
Contact: Vicky Wheeler     02077861342     v.wheeler@retroscreen.com    
Principal Investigator: Adeyemi Adeyi, MD            
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Adeyi Adeyemi, MD Retroscreen Virology
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01756482     History of Changes
Other Study ID Numbers: GS-US-218-0103
Study First Received: December 20, 2012
Last Updated: January 14, 2013
Health Authority: United Kingdom: National Health Service

Keywords provided by Gilead Sciences:
Respiratory
Syncytial
Virus
Infections
RSV

Additional relevant MeSH terms:
Respiratory Syncytial Virus Infections
Virus Diseases
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on May 19, 2013