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

NCT ID: NCT00079911

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-12

Study Completion Date

2004-10-15

Brief Summary

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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.

Detailed Description

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Conditions

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Herpes Genitalis

Keywords

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Herpes Genital Herpes HIV HSV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

valacyclovir hydrochloride

Intervention Type DRUG

valacyclovir hydrochloride

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.

Group Type PLACEBO_COMPARATOR

valacyclovir hydrochloride

Intervention Type DRUG

valacyclovir hydrochloride

Interventions

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valacyclovir hydrochloride

valacyclovir hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Altamonte Springs, Florida, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Boston, Massachusetts, United States

Site Status

GSK Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

GSK Investigational Site

Kowloon Bay, , Hong Kong

Site Status

Countries

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United States Australia Hong Kong

Other Identifiers

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100181

Identifier Type: -

Identifier Source: org_study_id