Clinical Trials For Genital Herpes Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

Herpes Simplex Type 2 Co-infection in Veterans With Chronic Hepatitis C

This study is currently recruiting participants.

Verified by G.V. (Sonny) Montgomery VA Medical Center, April 2010

First Received: December 22, 2009   Last Updated: April 21, 2010   History of Changes

Sponsor:

G.V. (Sonny) Montgomery VA Medical Center

Information provided by:

G.V. (Sonny) Montgomery VA Medical Center

ClinicalTrials.gov Identifier:

NCT01037621

Purpose

This trial is to determine the safety of valacyclovir in persons with chronic hepatitis C and herpes simplex type 2 infection. Participants will be randomized to valacyclovir or matching placebo. After receiving the initial therapy for eight weeks, the participants will cross over to the alternate therapy for an additional eight weeks. Each treatment period will be separated by a two-week period of daily placebo. The hypothesis is that treatment with valacyclovir will result in a significant reduction in serum levels of hepatitis C virus ribonucleic acid.


Condition

Intervention

Phase

Hepatitis C Virus Infection

Infection

Herpesvirus 2, Human

Drug: Valacyclovir

Phase I


Study Type:

Interventional

Study Design:

Allocation: Randomized

Control: Placebo Control

Endpoint Classification: Safety/Efficacy Study

Intervention Model: Crossover Assignment

Masking: Double Blind (Subject, Caregiver, Investigator)

Primary Purpose: Treatment

Official Title:

The Interaction of HSV-2 Co-infection in Veterans With Chronic Hepatitis C: the Effect of Valacyclovir on HCV Viral Load


Resource links provided by NLM:


MedlinePlus related topics: Hepatitis Hepatitis C Herpes Simplex

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources


Further study details as provided by G.V. (Sonny) Montgomery VA Medical Center:


Primary Outcome Measures:

The number of study participants who experience adverse events while receiving valacyclovir. [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]Tolerability assessments will be performed very two weeks while on study medications. Complete blood cell count, creatinine clearance and liver function tests will be performed every four weeks while on medications. Adverse events will be graded using the Division of AIDS Adverse Event Grading Table, Version 1.0, clarification August 2009. Based on previous clinical experience with valacyclovir, we expect the drug will be well-tolerated in patients with hepatitis C.


Secondary Outcome Measures:

The effect of valacyclovir compared with placebo to serum levels of HCV RNA [ Time Frame: 18 ] [ Designated as safety issue: No ]Serum HCV RNA will be measured at baseline and every four weeks while on study medication. We expect to see a decrease in HCV RNA >0.5 log10IU/mL during the valacyclovir phase compared with the placebo phase. The cross-over design will allow each patient to serve as their own control, providing data on the effect of HSV-2 suppression on HCV RNA.


Estimated Enrollment:

50

Study Start Date:

April 2010

Estimated Study Completion Date:

February 2011

Estimated Primary Completion Date:

February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Drug: Valacyclovir Valacyclovir 500 mg, 2 caplets twice daily for eight weeks

Eligibility


Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Clinical diagnosis of hepatitis C infection

Clinical diagnosis of herpes simplex type 2 infection

Exclusion Criteria:

HIV infection

Other forms of chronic liver disease

Chronic medical conditions

On immunosuppressive medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01037621


Locations

United States, Mississippi

G.V. Sonny Montgomery VA Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contact: Mary Jane Burton, M.D.     601-362-4471

Sponsors and Collaborators

G.V. (Sonny) Montgomery VA Medical Center

Investigators

Principal Investigator:

Mary Jane Burton, M.D.

G.V. (Sonny) Montgomery VA Medical Center

More Information


No publications provided


Responsible Party:

G.V. (Sonny) Montgomery VA Medical Center ( Mary Jane Burton, MD. )

ClinicalTrials.gov Identifier:

NCT01037621 History of Changes

Other Study ID Numbers:

VAL R 152, 2009-00348

Study First Received:

December 22, 2009

Last Updated:

April 21, 2010

Health Authority:

United States: Food and Drug Administration


Keywords provided by G.V. (Sonny) Montgomery VA Medical Center:

Herpes simplex type 2

Hepatitis C virus

Valacyclovir

Herpes Simplex virus type 2 infection


Additional relevant MeSH terms:

Herpes Simplex

Anti-Infective Agents

Liver Diseases

RNA Virus Infections

Skin Diseases

Hepatitis, Chronic

Flaviviridae Infections

Hepatitis, Viral, Human

Antiviral Agents

Pharmacologic Actions

Herpesviridae Infections

Valacyclovir

Skin Diseases, Viral

Hepatitis

Virus Diseases

Skin Diseases, Infectious

Acyclovir

Digestive System Diseases

Therapeutic Uses

DNA Virus Infections

Hepatitis C

Hepatitis C, Chronic


ClinicalTrials.gov processed this record on June 15, 2010