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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01756482
First received: December 20, 2012
Last updated: January 2, 2014
Last verified: January 2014
  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:


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


Enrollment: 140
Study Start Date: November 2012
Study Completion Date: June 2013
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

Locations
United Kingdom
Retroscreen Virology
London, United Kingdom, E12AX
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 2, 2014
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 April 20, 2014