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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01756482
Recruitment Status : Completed
First Posted : December 27, 2012
Last Update Posted : August 21, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: GS-5806 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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)
Study Start Date : November 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in viral load measurements. [ Time Frame: Post initial dose of GS-5806/placebo to Day 12 ]
    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 :
  1. Change of baseline symptoms [ Time Frame: Innoculation through Day 12 ]
    Change of baseline symptoms post initial dose of GS-5806 or placebo through Day 12


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01756482


Locations
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United Kingdom
Retroscreen Virology
London, United Kingdom, E12AX
Sponsors and Collaborators
Gilead Sciences
Investigators
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Principal Investigator: Adeyi Adeyemi, MD Retroscreen Virology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01756482    
Other Study ID Numbers: GS-US-218-0103
First Posted: December 27, 2012    Key Record Dates
Last Update Posted: August 21, 2015
Last Verified: August 2015
Keywords provided by Gilead Sciences:
Respiratory
Syncytial
Virus
Infections
RSV
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Infections
Virus Diseases
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections