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

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00079911

Purpose

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.

Condition	Intervention	Phase
Genital Herpes HIV Infection	Drug: valacyclovir hydrochloride	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: Genital Herpes HIV/AIDS

Drug Information available for: Valaciclovir Valacyclovir hydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	162
Study Start Date:	March 2004
Study Completion Date:	October 2004
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Intervention Details:

Other Name: valacyclovir hydrochloride

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079911

Locations

United States, Colorado
GSK Investigational Site
Denver, Colorado, United States, 80204
United States, Florida
GSK Investigational Site
Altamonte Springs, Florida, United States, 32701
GSK Investigational Site
Fort Myers, Florida, United States, 33901
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60657
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02115
United States, New Jersey
GSK Investigational Site
Voorhees, New Jersey, United States, 08043
United States, New York
GSK Investigational Site
Rochester, New York, United States, 14604
United States, South Carolina
GSK Investigational Site
Columbia, South Carolina, United States, 29206-4713
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75246
GSK Investigational Site
Fort Worth, Texas, United States, 76104
Australia, New South Wales
GSK Investigational Site
Darlinghurst, New South Wales, Australia, 2010
Hong Kong
GSK Investigational Site
Kowloon Bay, Hong Kong

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00079911 History of Changes
Other Study ID Numbers:	100181
Study First Received:	March 18, 2004
Last Updated:	September 28, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Herpes
HIV
HSV
Genital Herpes

Additional relevant MeSH terms:

HIV Infections
Acquired Immunodeficiency Syndrome
Herpes Genitalis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012