A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2004

Last Updated Date

October 15, 2008

Start Date ^ICMJE

March 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00079911 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary outcome measures are the proportion of subjects recurrence-free of genital HSV at 6 months, and the time to first culture-positive recurrence of genital HSV.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons

Official Title ^ICMJE

An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3.

Brief Summary

This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count <100 cells/mm3.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Condition ^ICMJE

Genital Herpes
HIV Infection

Intervention ^ICMJE

Drug: valacyclovir hydrochloride

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

162

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

CD4+ lymphocyte count <100cells/mm3 at the screening visit.
Documented history of HIV infections
Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.

Exclusion Criteria:

Kidney diseases.
Liver diseases.
Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir).
Vomiting syndrome.
Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
Active AIDS-indicator conditions, as defined by CDC Category C.
Other protocol inclusion and exclusion criteria to be evaluated by the research physician.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Hong Kong

Administrative Information

NCT ID ^ICMJE

NCT00079911

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

100181

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP