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

Overview

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

Full Title of Study: “A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Ranging Study Evaluating the Safety, Tolerability, and Pharmacokinetics of GS-5806 in Subjects < 24 Months of Age Hospitalized for Respiratory Syncytial Virus (RSV) Related Respiratory Infection”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2013

Interventions

  • Drug: GS-5806
    • Single dose, oral liquid, .5 mL/kg
  • Drug: Placebo
    • Single dose, oral liquid, .5 mL/kg

Arms, Groups and Cohorts

  • Experimental: GS-5806
    • Single dose, oral liquid, .5 mL/kg
  • Placebo Comparator: Placebo
    • Single dose, oral liquid, .5 mL/kg

Clinical Trial Outcome Measures

Primary Measures

  • Safety and tolerability
    • Time Frame: 10 days from subject randomization to study drug
    • Safety and tolerability will be assessed by evaluating AE’s, laboratory abnormalities and vital sign measurements.

Secondary Measures

  • Pharmacokinetics effects of GS-5806
    • Time Frame: 10 days from subject randomization to study drug
    • Evaluation of GS-5806 on viral load related and symptom related endpoints.

Participating in This Clinical Trial

Inclusion Criteria

  • <24 months of age – Diagnosis of Respiratory Syncytial Virus (RSV) within 48 hours of screening Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 1 Hour

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Gilead Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Peter Sly, MD, Principal Investigator, Queensland Children’s Medical Research Unit, Herston, AUS

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