Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes

Study Overview
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Brief Summary
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To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects.

Official Title
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A Single Center, Open Label, Longitudinal Single Arm Study to Compare the Efficacy and Safety of Prophylactic Famciclovir 500 mg b.d. in HIV Positive Adults With Recurrent Genital Herpes.

Conditions
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HIV Positive, Herpes Simplex, Genital

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive, gential HSV,Famvir™ 500mg bd, suppressive<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy | 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 | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent genital Herpes Simplex Virus