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WithdrawnNCT01797419Updated Oct 28, 2013

Safety Study of GS-5806 to Treat Respiratory Syncytial Virus (RSV)

A Phase 1 interventional study of GS-5806 and Placebo in Respiratory Syncytial Virus Infections, sponsored by Gilead Sciences. Withdrawn at 9 sites in Australia. Open to participants aged 1 Hour to 24 Months. Per ClinicalTrials.gov, last updated 2013-10-28.

Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
1 Hour to 24 Months
Sex
All
01

Study summary

The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of GS-5806 in hospitalized infants with RSV.

02

Conditions studied

  • Respiratory Syncytial Virus Infections

Keywords

  • Respiratory
  • Syncytial
  • Virus
  • RSV
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

Browse Infections studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • \<24 months of age
  • Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening

Exclusion criteria

Exclusion Criteria:

  • Chronic or congenital heart disease
  • Required ventilation or admission to any pediatric Intensive Care Unit
  • Inadequate organ function
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    GS-5806

    Single dose, oral liquid, .5 mL/kg

    Drug: GS-5806

  • Placebo comparator
    Placebo

    Single dose, oral liquid, .5 mL/kg

    Drug: Placebo

Interventions

  • DrugGS-5806

    Single dose, oral liquid, .5 mL/kg

  • DrugPlacebo

    Single dose, oral liquid, .5 mL/kg

06

What researchers measure

Primary outcomes

  1. Safety and tolerability

    Safety and tolerability will be assessed by evaluating AE's, laboratory abnormalities and vital sign measurements.

    Time frame: 10 days from subject randomization to study drug

Secondary outcomes

  1. Pharmacokinetics effects of GS-5806

    Evaluation of GS-5806 on viral load related and symptom related endpoints.

    Time frame: 10 days from subject randomization to study drug

07

Study locations

9 sites
  • Geelong Hospital
    Geelong, Victoria 3220, Australia
  • Monash Medical Center
    Clayton, Australia
  • Queensland Children's Medical Research Unit
    Herston, Australia
  • Royal Hobart Hospital
    Hobart, Australia
  • Women's and Children's Hospital Adelaide
    North Adelaide, Australia
  • Royal Children's Hospital
    Parkville, Australia
  • Sydney Children's Hospital
    Randwick, Australia
  • Princess Margaret Hospital for Children
    Subiaco, Australia
  • Westmead Children's Hospital
    Westmead, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01797419
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Feb 22, 2013
Start date
May 2013
Primary completion
Aug 2013 (estimated)
Completion
Aug 2013 (estimated)
Last update
Oct 28, 2013

Study contacts

Peter Sly, MD
principal investigator · Queensland Children's Medical Research Unit, Herston, AUS

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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