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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 4

Conditions: Herpes Genitalis

Treatments: Drug: valacyclovir hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00079911

100181

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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7 participants in 2 patient groups, including a placebo group

Suppressive + Episodic Therapy

Experimental group

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.

Treatment:

Drug: valacyclovir hydrochloride

Episodic Therapy

Placebo Comparator group

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.

Treatment:

Drug: valacyclovir hydrochloride