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

Phase 4

Terminated

• Conditions: Herpes Genitalis
• Interventions: Drug: valacyclovir hydrochloride

• Registration Number: NCT00079911
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03-12
• Study First Submitted: 2004-03-18
• Study First Submitted QC: 2004-03-18
• Study First Posted: 2004-03-19
• Primary Completion: 2004-10-15
• Study Completion: 2004-10-15
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Episodic Therapy	valacyclovir hydrochloride	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.
Suppressive + Episodic Therapy	valacyclovir hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events	Up to 6 months	The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.

Secondary Outcome Measures

Name	Time	Method
Proportion of recurrence of genital HSV	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.
Time to first culture-positive recurrence of genital HSV	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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇭🇰 Kowloon Bay, Hong Kong