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

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

This study has been terminated.

Study NCT00079911. Last updated on October 15, 2008. Information provided by GlaxoSmithKline

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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.

Condition ^†

Genital Herpes
HIV Infection

Intervention ^†

Drug: valacyclovir hydrochloride

MEDLINE PMIDs

Links

A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

162

Start Date ^†

March 2004

Completion Date

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States, Australia, Hong Kong

Administrative Information Fields

NCT ID ^†

NCT00079911

Organization ID

100181

Secondary IDs ^††

Study Sponsor ^†

GlaxoSmithKline

Collaborators ^††

Investigators ^†

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

October 2008

First Received Date ^†

March 18, 2004

Last Updated Date

October 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.