Efficacy, Pharmacokinetics, and Safety of Presatovir in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection
|ClinicalTrials.gov Identifier: NCT02135614|
Recruitment Status : Completed
First Posted : May 12, 2014
Last Update Posted : November 17, 2017
This study is to evaluate the antiviral effect, pharmacokinetics, safety, and tolerability of presatovir in respiratory syncytial virus (RSV) positive adults who have been hospitalized with acute respiratory infectious symptoms.
Participants will receive 1 dose of presatovir and followed for 28 days postdose. Nasal swabs will be collected at each study visit (excluding Day 28) and assayed for change in viral load as the primary endpoint.
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Syncytial Virus (RSV) Infections||Drug: Presatovir Drug: Presatovir placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hospitalized Adults With Respiratory Syncytial Virus (RSV) Infection|
|Actual Study Start Date :||June 9, 2014|
|Actual Primary Completion Date :||March 27, 2017|
|Actual Study Completion Date :||April 12, 2017|
Participants will receive a single dose of presatovir.
Presatovir 200 mg (4 x 50 mg tablets) administered orally
Other Name: GS-5806
Placebo Comparator: Presatovir placebo
Participants will receive a single dose of presatovir placebo.
Drug: Presatovir placebo
Presatovir placebo tablets administered orally
- Time-weighted average change in respiratory syncytial viral load [ Time Frame: Day 1 to Day 5 ]The time-weighted average change in log10 viral load from Day 1 to Day 5 will be assessed.
- Time-weighted average change in the FLU-PRO score [ Time Frame: Day 1 to Day 5 ]The FLU-PRO is a patient-reported outcome questionnaire utilized as a standardized method for evaluating symptoms of influenza.
- Duration of hospital stay following presatovir administration [ Time Frame: Up to 28 days ]
- Rate of unplanned medical encounters [ Time Frame: Up to 28 days ]The rate of unplanned medical encounters (clinic visits, emergency room visits, urgent care visits, and rehospitalizations) related to a respiratory illness after initial hospital discharge through Day 28 will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135614
Show 43 Study Locations
|Study Director:||Gilead Study Director||Gilead Sciences|