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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.
(Terminated)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00079911
First Posted: March 19, 2004
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Herpes Genitalis Drug: valacyclovir hydrochloride Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 6 months ]
    The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.


Secondary Outcome Measures:
  • Proportion of recurrence of genital HSV [ Time Frame: Up to 6 months ]
    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.

  • Time to first culture-positive recurrence of genital HSV [ Time Frame: Up to 6 months ]
    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.


Enrollment: 7
Actual Study Start Date: March 14, 2004
Study Completion Date: October 15, 2004
Primary Completion Date: October 15, 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suppressive + Episodic Therapy
Valaciclovir (VAL) 500mg twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 days or 10 days, when required for treatment of a genital herpes recurrence.
Drug: valacyclovir hydrochloride
valacyclovir hydrochloride
Placebo Comparator: Episodic Therapy
Matching placebo twice daily for 6 months, and episodic treatment with VAL 1000mg twice daily for 5 or 10 days, when required for treatment of a genital herpes recurrence.
Drug: valacyclovir hydrochloride
valacyclovir hydrochloride

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 GlaxoSmithKline
  More Information

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 100181
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00079911     History of Changes
Other Study ID Numbers: 100181
First Submitted: March 18, 2004
First Posted: March 19, 2004
Last Update Posted: August 7, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:
Herpes
Genital Herpes
HIV
HSV

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Valacyclovir
Acyclovir
Antiviral Agents
Anti-Infective Agents