Suspended

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.

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What is being tested

valacyclovir hydrochloride

Drug
Who is being recruted

Urogenital Diseases+16

+ Genital Diseases

+ Communicable Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: March 2004
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 12, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleAn 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. 
Principal SponsorGlaxoSmithKline
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

7 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesCommunicable DiseasesDNA Virus InfectionsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleHerpes GenitalisHerpes SimplexHerpesviridae InfectionsInfectionsSexually Transmitted DiseasesSkin DiseasesSkin Diseases, InfectiousVirus DiseasesSexually Transmitted Diseases, ViralSkin Diseases, ViralFemale Urogenital DiseasesMale Urogenital Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
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.

Group II

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

GSK Investigational Site

Altamonte Springs, United StatesSee the location
Suspended

GSK Investigational Site

Chicago, United States
Suspended

GSK Investigational Site

Boston, United States
Suspended

GSK Investigational Site

Darlinghurst, Australia
Suspended5 Study Centers