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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
7
valacyclovir hydrochloride
GSK Investigational Site
Altamonte Springs, Florida, United States
GSK Investigational Site
Chicago, Illinois, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Darlinghurst, New South Wales, Australia
Adverse Events
The nature and incidence of adverse events, by treatment group, reported during the 6-month study will be summarized.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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GSK Investigational Site
Kowloon Bay, Hong Kong