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
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, see Learn About Clinical Studies.

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 by Gilead Sciences

Additional 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
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 August 26, 2014