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

Gilead Sciences

Status and phase: Withdrawn; Phase 1

Conditions: Respiratory Syncytial Virus Infections

Treatments: Drug: Placebo; Drug: GS-5806

Study type: Interventional

Funder types: Industry

Identifiers

NCT01797419

GS-US-218-0104

Details and patient eligibility

About

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

Sex: All

Ages: 1 hour to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

GS-5806

Experimental group

Description:

Single dose, oral liquid, .5 mL/kg

Treatment:

Drug: GS-5806

Placebo

Placebo Comparator group

Description:

Single dose, oral liquid, .5 mL/kg

Treatment:

Drug: Placebo