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

This study has been completed.
Sponsor:
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
  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.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
HIV positive, gential HSV,Famvir™ 500mg bd, suppressive

  Eligibility

Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Holdsworth House Medical Practice:
Recurrent genital Herpes Simplex Virus

Additional relevant MeSH terms:
Herpes Genitalis
Herpes Simplex
HIV Seropositivity
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Genital Diseases, Male
Genital Diseases, Female
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Famciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 14, 2014