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

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

valacyclovir hydrochloride

About this trial

This is an interventional treatment trial for Herpes Genitalis focused on measuring Herpes, Genital Herpes, HIV, HSV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site
GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Suppressive + Episodic Therapy

Episodic Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Adverse Events

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

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

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.

Full Information

NCT ID

NCT00079911

First Posted

March 18, 2004

Last Updated

November 20, 2020

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00079911

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Terminated

Why Stopped

Terminated

Study Start Date

March 12, 2004 (Actual)

Primary Completion Date

October 15, 2004 (Actual)

Study Completion Date

October 15, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Herpes Genitalis

Keywords

Herpes, Genital Herpes, HIV, HSV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Suppressive + Episodic Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Episodic Therapy

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

valacyclovir hydrochloride

Intervention Description

valacyclovir hydrochloride

Primary Outcome Measure Information:

Title

Adverse Events

Description

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

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Proportion of recurrence of genital HSV

Description

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 Frame

Up to 6 months

Title

Time to first culture-positive recurrence of genital HSV

Description

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 Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Altamonte Springs

State/Province

Florida

ZIP/Postal Code

32701

Country

United States

Facility Name

GSK Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60657

Country

United States

Facility Name

GSK Investigational Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

GSK Investigational Site

City

Darlinghurst

State/Province

New South Wales

ZIP/Postal Code

2010

Country

Australia

Facility Name

GSK Investigational Site

City

Kowloon Bay

Country

Hong Kong

Herpes Genitalis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial