A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Herpes Genitalis; HIV Infections
Intervention: valacyclovir hydrochloride (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trial, MD, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Primary outcome: The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, Beverly Hills, California 90211, United States
GSK Clinical Trials Call Center, Denver, Colorado 80104, United States
GSK Clinical Trials Call Center, Altamonte Springs, Florida 32701, United States
GSK Clinical Trials Call Center, Fort Myers, Florida 33901, United States
GSK Clinical Trials Call Center, Chicago, Illinois 60657, United States
GSK Clinical Trials Call Center, Boston, Massachusetts 02115, United States
GSK Clinical Trials Call Center, St. Louis, Missouri 63108, United States
GSK Clinical Trials Call Center, Voorhees, New Jersey 08043, United States
GSK Clinical Trials Call Center, Dallas, Texas 75246, United States
GSK Clinical Trials Call Center, Fort Worth, Texas 76104, United States
GSK Clinical Trials Call Center, Seattle, Washington 98122, United States
Additional Information
A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.
Starting date: January 2005
Last updated: August 11, 2006
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