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

November 20, 2020 updated by: GlaxoSmithKline

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • GSK Investigational Site
  • Hong Kong
      • Kowloon Bay, Hong Kong
        • GSK Investigational Site
  • United States
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • GSK Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60657
        • GSK Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months
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.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2004

Primary Completion (Actual)

October 15, 2004

Study Completion (Actual)

October 15, 2004

Study Registration Dates

First Submitted

March 18, 2004

First Submitted That Met QC Criteria

March 18, 2004

First Posted (Estimate)

March 19, 2004

Study Record Updates

Last Update Posted (Actual)

November 24, 2020

Last Update Submitted That Met QC Criteria

November 20, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 100181

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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