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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
GS-5806
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring Respiratory, Syncytial, Virus, Infections, RSV

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Retroscreen Virology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GS-5806

Sugar powder for oral solution in juice

Arm Description

GS-5806, powder for oral solution

Sugar powder for oral solution

Outcomes

Primary Outcome Measures

Change in viral load measurements.
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
Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12

Full Information

First Posted
December 20, 2012
Last Updated
August 3, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01756482
Brief Title
Safety and Efficacy Study of GS-5806 in Healthy Volunteers Infected With Respiratory Syncytial Virus (RSV)
Acronym
Challenge
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
Respiratory, Syncytial, Virus, Infections, RSV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GS-5806
Arm Type
Experimental
Arm Description
GS-5806, powder for oral solution
Arm Title
Sugar powder for oral solution in juice
Arm Type
Placebo Comparator
Arm Description
Sugar powder for oral solution
Intervention Type
Drug
Intervention Name(s)
GS-5806
Intervention Description
GS-5806, powder for oral solution
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in viral load measurements.
Description
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.
Time Frame
Post initial dose of GS-5806/placebo to Day 12
Secondary Outcome Measure Information:
Title
Change of baseline symptoms
Description
Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12
Time Frame
Innoculation through Day 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adeyi Adeyemi, MD
Organizational Affiliation
Retroscreen Virology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retroscreen Virology
City
London
ZIP/Postal Code
E12AX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25140957
Citation
DeVincenzo JP, Whitley RJ, Mackman RL, Scaglioni-Weinlich C, Harrison L, Farrell E, McBride S, Lambkin-Williams R, Jordan R, Xin Y, Ramanathan S, O'Riordan T, Lewis SA, Li X, Toback SL, Lin SL, Chien JW. Oral GS-5806 activity in a respiratory syncytial virus challenge study. N Engl J Med. 2014 Aug 21;371(8):711-22. doi: 10.1056/NEJMoa1401184.
Results Reference
derived

Learn more about this trial

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

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