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

HIV Positive Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154543
• Other study ID #: Famvir™ 500 in HIV
• Status: Completed
• Phase: N/A
• First received: June 30, 2010
• Last updated: March 19, 2013
• Start date: March 2008
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: Holdsworth House Medical Practice
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: February 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Herpes Genitalis
• Herpes Simplex
• Herpes Simplex, Genital
• HIV Positive
• HIV Seropositivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Holdsworth House Medical Practice

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No