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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Holdsworth House Medical Practice


Information provided by (Responsible Party)
Dr. Mark Bloch, Holdsworth House Medical Practice

ClinicalTrials.gov Identifier
NCT01154543

First received: June 30, 2010
Last updated: March 19, 2013
Last Verified: March 2013
History of Changes
Purpose

Purpose

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

Condition
HIV Positive
Herpes Simplex, Genital

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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.

Further study details as provided by Dr. Mark Bloch, Holdsworth House Medical Practice:

Primary Outcome Measures

  • 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

Enrollment: 42
Study Start Date: March 2008
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms
HIV positive, gential HSV,Famvir™ 500mg bd, suppressive

Eligibility

Eligibility

Ages Eligible for Study: Child, Adult, Senior  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  
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.

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154543

Sponsors and Collaborators

Holdsworth House Medical Practice

Investigators

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

More Information


Responsible Party: Dr. Mark Bloch, Dr Mark Bloch, Holdsworth House Medical Practice  
ClinicalTrials.gov Identifier: NCT01154543   History of Changes  
Other Study ID Numbers: Famvir™ 500 in HIV  
Study First Received: June 30, 2010  
Last Updated: March 19, 2013  

Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:

Recurrent genital Herpes Simplex Virus

Additional relevant MeSH terms:
HIV Seropositivity
Herpes Simplex
Herpes Genitalis
Famciclovir

ClinicalTrials.gov processed this data on October 16, 2017
This information is provided by ClinicalTrials.gov.