Conditions: Respiratory Syncytial Virus
Keywords: Respiratory Syncytial Virus (RSV) Antiviral Hematopoietic Cell Transplant (HCT) Upper respiratory tract infection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 189
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV upper respiratory tract infection (URTI), the effect of presatovir on development of lower respiratory tract complication, being free of any supplemental oxygen progression to respiratory failure, and pharmacokinetics (PK), safety, and tolerability of presatovir.

Detailed description:

Arms:
arm 1: Participants will receive presatovir on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56. arm 2: Participants will receive placebo on Days 1, 5, 9, 13, and 17, with follow-up visits through Day 28, and may continue in an optional extended monitoring phase with visits through Day 56.

Interventions: intervention 1: Presatovir intervention 2: Placebo
Intervention descriptions: intervention 1: Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube intervention 2: Tablets administered orally or via nasogastric tube

Protocol document:
Prot_003.pdf: 


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Prot_002.pdf: 


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Presatovir (GS-5806)
Protocol GS-US-218-0108
Final
Gilead Sciences, Inc.
Amendment 7
CONFIDENTIAL
Page 69
28 March 2016
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The co-primary objectives of this study are:

To evaluate the effect of presatovir on RSV viral load and development of LRTC in RSV-
positive autologous or allogeneic HCT recipients with acute URTI symptoms
The secondary objectives of this study are:

To evaluate the effect of presatovir on development progression to respiratory failure or all-
cause mortality

To evaluate the PK, safety, and tolerability of presatovir
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The co-primary efficacy endpoints of this study are: the time-weighted average change in nasal 
RSV viral load (log10 copies/mL) from Baseline (Day 1) to Day 9 and the proportion of subjects 
who develop a LRTC through Day 28. The time-weighted average change in nasal RSV viral 
load from Baseline to Day 9 is defined as:
∑
  ሼ0.5 ൈ ሺܻ௜൅ܻ௜ାଵሻൈሺݐ௜ାଵെݐ௜ሻሽ 
௕ିଵ
௜ୀ௔
ሺݐ௕െݐ௔ሻ
where <i is the change from Baseline in RSV log10 viral load at 9LVLW L, W is the time at the 
specified timepoint, D is the baseline assessment at Day 1 and E is the last assessment at or prior 
to Day 9. The time-weighted average change, often referred to as the DAVG, provides the 
average viral burden in change from baseline during the time period of interest.
The proportion of subjects who develop a LRTC through Day 28, defined as 1 of the below, will 
be adjudicated by an Endpoint Adjudication Committee (EAC).  

Primary RSV LRTI

Secondary bacterial LRTI

Lower respiratory tract infection due to unusual pathogens

Lower respiratory tract complication of unknown etiology




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