Trial Outcomes & Findings for Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I) (NCT NCT01453075)

Results Overview

Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

baseline; 12 weeks

Results posted on

2016-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Valacyclovir Assigned patients will take 1.5 mg po valacyclovir twice daily Valacyclovir: Valacyclovir 1.5 mg po bid	Arm 2: Placebo Assigned patients will receiving matching placebo twice daily Placebo: Matching placebo twice daily
Overall Study STARTED	16	15
Overall Study COMPLETED	11	14
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating Three Grams Daily Valacyclovir in Patients With Chronic Hepatitis C and HSV-2 Infection (Phase I)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Valacyclovir n=16 Participants Assigned patients will take 1.5 mg po valacyclovir twice daily Valacyclovir: Valacyclovir 1.5 mg po bid	Arm 2: Placebo n=15 Participants Assigned patients will receiving matching placebo twice daily Placebo: Matching placebo twice daily	Total n=31 Participants Total of all reporting groups
Age, Continuous	58.8 years STANDARD_DEVIATION 3.5 • n=5 Participants	58.8 years STANDARD_DEVIATION 3.5 • n=7 Participants	58.8 years STANDARD_DEVIATION 3.5 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline; 12 weeks

Population: Analyzed patients who completed study

Measure the change in serum HCV viral load at baseline and 12 weeks in patients who have chronic hepatitis C and HSV-2 infection who receive the 3 grams daily valacyclovir versus placebo

Outcome measures

Outcome measures
Measure	Arm 1: Valacyclovir n=11 Participants Assigned patients will take 1.5 mg po valacyclovir twice daily Valacyclovir: Valacyclovir 1.5 mg po bid	Arm 2: Placebo n=14 Participants Assigned patients will receiving matching placebo twice daily Placebo: Matching placebo twice daily
Effect of HSV-2 Suppression on HCV Viral Load.	.18 log(IU/mL) Standard Error .104	.03 log(IU/mL) Standard Error .75

Adverse Events

Arm 1: Valacyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mary Jane Burton

VA ORD

Phone: 6013624471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place