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.
valacyclovir hydrochloride
Urogenital Diseases+16
+ Genital Diseases
+ Communicable Diseases
Treatment Study
Summary
Study start date: March 12, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.7 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
GSK Investigational Site
Chicago, United StatesGSK Investigational Site
Boston, United StatesGSK Investigational Site
Darlinghurst, Australia