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

March 19, 2013 updated by: Dr. Mark Bloch, Holdsworth House Medical Practice

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.

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV positive, gential HSV,Famvir™ 500mg bd, suppressive

What is the study measuring?

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)
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
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
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holdsworth House Medical Practice

Investigators

  • Principal Investigator: Mark T Bloch, MBBS, Australian Health Practitioners Regulation authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (ESTIMATE)

July 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 20, 2013

Last Update Submitted That Met QC Criteria

March 19, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Famvir™ 500 in HIV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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