CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Valacyclovir +1 moredrug
Likely dose
Valacyclovir 1.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01453075
NCT01453075Phase 1Completed

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

VA Office of Research and Development·interventional·Posted Oct 17, 2011·Updated Nov 22, 2016

In Brief

A Phase 1 clinical trial evaluating Valacyclovir and Placebo for Chronic Hepatitis C Infection. Completed, enrolled 31 participants across 1 site.

Detailed Summary

The purpose of this study is to study the effects of valacyclovir on patients who have hepatitis C and antibodies to herpes simplex type-2. Herpes simplex type 2 is a virus which causes genital herpes. Some persons with genital herpes have sores in their private areas but most persons do not have any symptoms at all. Valacyclovir is a medication which is commonly used to treat or prevent outbreaks of genital herpes. This medication is already approved by the Food and Drug Administration to treat genital herpes. Valacyclovir has not been approved to treat chronic hepatitis C. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and the persons participating will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 3-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGlaxoSmithKline

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2011
Enrollment StartNov 1, 2011
Primary CompletionJul 1, 2015
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 14.7 years ago

Interventions

Valacyclovirdrug

Valacyclovir 1.5 mg po bid

Placebodrug

Matching placebo twice daily