Herpes Genitalis
Conditions
Keywords
Herpes, Genital Herpes, HIV, HSV
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.
Interventions
valacyclovir hydrochloride
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Hong Kong, United States
Outcome results
None listed