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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01756482
First Posted: December 27, 2012
Last Update Posted: August 21, 2015
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.
Information provided by (Responsible Party):
Gilead Sciences
  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
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)

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 ]
    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 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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
United Kingdom
Retroscreen Virology
London, United Kingdom, E12AX
Sponsors and Collaborators
Gilead Sciences
Investigators
Principal Investigator: Adeyi Adeyemi, MD Retroscreen Virology
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01756482     History of Changes
Other Study ID Numbers: GS-US-218-0103
First Submitted: December 20, 2012
First Posted: December 27, 2012
Last Update Posted: August 21, 2015
Last Verified: August 2015

Keywords provided by Gilead Sciences:
Respiratory
Syncytial
Virus
Infections
RSV

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