Full Text View
Tabular View
No Study Results Posted
Related Studies
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
This study has been terminated.
Study NCT00079911   Information provided by GlaxoSmithKline
First Received: March 18, 2004   Last Updated: October 15, 2008   History of Changes

March 18, 2004
October 15, 2008
March 2004
 
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Same as current
Complete list of historical versions of study NCT00079911 on ClinicalTrials.gov Archive Site
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.
Same as current
 
A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
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.

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.

 
Phase IV
Interventional
Treatment, Randomized, Double-Blind, Safety/Efficacy Study
  • Genital Herpes
  • HIV Infection
Drug: valacyclovir hydrochloride
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
162
 
 

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Hong Kong
 
NCT00079911
Study Director, GSK
100181
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

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