NCT00079911

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_4

Geographic Reach
3 countries

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 12, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2004

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2004

Completed
Last Updated

November 24, 2020

Status Verified

November 1, 2020

Enrollment Period

7 months

First QC Date

March 18, 2004

Last Update Submit

November 20, 2020

Conditions

Herpes Genitalis

Keywords

HerpesGenital HerpesHIVHSV

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.

    Up to 6 months

Secondary Outcomes (2)

  • Proportion of recurrence of genital HSV

    Up to 6 months

  • Time to first culture-positive recurrence of genital HSV

    Up to 6 months

Study Arms (2)

Suppressive + Episodic Therapy

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.

Drug: valacyclovir hydrochloride

Episodic Therapy

PLACEBO COMPARATOR

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

Interventions

valacyclovir hydrochlorideDRUG

valacyclovir hydrochloride

Episodic TherapySuppressive + Episodic Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
  • or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

GSK Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

GSK Investigational Site

Chicago, Illinois, 60657, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02115, United States

Location

GSK Investigational Site

Darlinghurst, New South Wales, 2010, Australia

Location

GSK Investigational Site

Kowloon Bay, Hong Kong

Location

MeSH Terms

Conditions

Herpes GenitalisHerpes Simplex

Interventions

Valacyclovir

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Diseases, MaleMale Urogenital DiseasesSkin Diseases, ViralSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2004

First Posted

March 19, 2004

Study Start

March 12, 2004

Primary Completion

October 15, 2004

Study Completion

October 15, 2004

Last Updated

November 24, 2020

Record last verified: 2020-11

Locations

US(3)AU(1)HK(1)