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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.

Sponsored by: 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

MedlinePlus related topics:   AIDS   

Drug Information available for:   Valaciclovir    Valacyclovir hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Safety/Efficacy Study
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.

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

  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


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Responsible Party:   GSK ( Study Director )
Study ID Numbers:   100181
First Received:   March 18, 2004
Last Updated:   October 15, 2008
ClinicalTrials.gov Identifier:   NCT00079911
Health Authority:   United States: Food and Drug Administration;   United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Herpes  
HIV  
HSV  
Genital Herpes  

Study placed in the following topic categories:
Herpes Simplex
Sexually Transmitted Diseases, Viral
Herpes Genitalis
Acquired Immunodeficiency Syndrome
Genital Diseases, Male
Immunologic Deficiency Syndromes
Herpesviridae Infections
Valacyclovir
Virus Diseases
Genital Diseases, Female
Acyclovir
HIV Infections
Sexually Transmitted Diseases
DNA Virus Infections
Retroviridae Infections

Additional relevant MeSH terms:
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Therapeutic Uses
Lentivirus Infections
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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