Trial Outcomes & Findings for Herpes Simplex Type 1 Suppression in Hepatitis C (NCT NCT01580995)

NCT ID: NCT01580995

Last Updated: 2016-09-21

Results Overview

Measure change in HCV RNA viral load in treatment group as compared with placebo

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

Baseline, 12 weeks

Results posted on

2016-09-21

Participant Flow

Participant milestones

Participant milestones
Measure	Valacyclovir Valacyclovir 500 mg po bid Valacyclovir: Valacyclovir 500 mg po bid	Placebo Matching placebo twice daily Placebo: Placebo tablet twice daily
Overall Study STARTED	10	9
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Valacyclovir Valacyclovir 500 mg po bid Valacyclovir: Valacyclovir 500 mg po bid	Placebo Matching placebo twice daily Placebo: Placebo tablet twice daily
Overall Study Lost to Follow-up	2	2

Baseline Characteristics

Herpes Simplex Type 1 Suppression in Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Valacyclovir n=10 Participants Valacyclovir 500 mg po bid Valacyclovir: Valacyclovir 500 mg po bid	Placebo n=9 Participants Matching placebo twice daily Placebo: Placebo tablet twice daily	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants	9 Participants n=107 Participants	19 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	55 years STANDARD_DEVIATION 2 • n=99 Participants	57 years STANDARD_DEVIATION 3 • n=107 Participants	56 years STANDARD_DEVIATION 2 • n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	10 Participants n=99 Participants	9 Participants n=107 Participants	19 Participants n=206 Participants
Region of Enrollment United States	10 participants n=99 Participants	9 participants n=107 Participants	19 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks

Population: patients who completed 12 weeks of follow up

Measure change in HCV RNA viral load in treatment group as compared with placebo

Outcome measures

Outcome measures
Measure	Valacyclovir n=8 Participants Valacyclovir 500 mg po bid Valacyclovir: Valacyclovir 500 mg po bid	Placebo n=7 Participants Matching placebo twice daily Placebo: Placebo tablet twice daily
Change in HCV RNA Viral Load	.24 log(IU/mL) Standard Deviation .20	.08 log(IU/mL) Standard Deviation .01

Adverse Events

Valacyclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

VAORD

Phone: 6013624471

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place