Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes
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To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months) [ Time Frame: 24 months ]
To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)and to determine the safety of Famciclovir 500mg bd in this population
Secondary Outcome Measures
To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy [ Time Frame: 24 months ]
To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy To determine virological & immunological parameters of HIV whilst taking Famciclovir 500 mg as suppressive antiviral therapy To determine patient adherence to Famciclovir 500 mg bd over the study period To determine the incidence of oral HSV outbreaks in subjects taking Famciclovir 500 mg bd as suppressive antiviral therapy
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Ages Eligible for Study:
Child, Adult, Senior
Sexes Eligible for Study:
Accepts Healthy Volunteers:
50-60 patients attending Holdsworth House Medical Practice in Darlinghurst, Sydney, New South Wales with documented HIV-1 infection who are taking Famciclovir 500mg bd as suppressive therapy for management of genital HSV infection who agree to participate in this study will be enrolled after signing HREC approved informed consent.
Able to provide signed informed consent
Documented HIV infection
In general good health, without other serious medical conditions as deemed by the investigator
Male or female over 18 years of age
Diagnosed genital HSV (clinical or laboratory)
Life expectancy of 12 months or longer per investigator's judgment
Stable on Famvir 500 mg bd for at least 30 days at time of screening
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (>5)mIU/mL).
Women of childbearing potential who are unwilling to use reliable contraception for the duration of the study.
History of hypersensitivity to Famvir, its constituents or penciclovir
Current use of another antiherpetic medication
Recent history of alcohol or drug abuse, which in the opinion of the investigator may interfere with their compliance with study requirements, or who have any other conditions which in the opinion of the investigator would interfere with the successful completion of study procedures
Disorder or condition that could interfere with drug absorption, distribution, metabolism or excretion
Known or suspected to have or past history of renal dysfunction requiring a dosage modification of Famvir 500 bd