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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.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00079911
First received: March 18, 2004
Last updated: September 28, 2010
Last verified: September 2010

March 18, 2004
September 28, 2010
March 2004
October 2004   (final data collection date for primary outcome measure)
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Not Provided
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.
Not Provided
Not Provided
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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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Genital Herpes
  • HIV Infection
Drug: valacyclovir hydrochloride
Other Name: valacyclovir hydrochloride
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
162
October 2004
October 2004   (final data collection date for primary outcome measure)

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
100181
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
September 2010

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