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

Herpes Genitalis Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00079911
• Other study ID #: 100181
• Status: Terminated
• Phase: Phase 4
• Start date: March 12, 2004
• Est. completion date: October 15, 2004

Study information

• Verified date: November 2020
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: October 15, 2004
• Est. primary completion date: October 15, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Genitalis

Intervention

Drug:
• valacyclovir hydrochloride
valacyclovir hydrochloride

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Darlinghurst	New South Wales
Hong Kong	GSK Investigational Site	Kowloon Bay
United States	GSK Investigational Site	Altamonte Springs	Florida
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Up to 6 months
Secondary	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.	Up to 6 months