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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154543
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : March 20, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Mark Bloch, Holdsworth House Medical Practice

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

Condition or disease
HIV Positive Herpes Simplex, Genital

Study Design
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Study Type : Observational
Actual Enrollment : 42 participants
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.
Study Start Date : March 2008
Actual Primary Completion Date : January 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Famciclovir

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154543


Sponsors and Collaborators
Holdsworth House Medical Practice
Investigators
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Principal Investigator: Mark T Bloch, MBBS Australian Health Practitioners Regulation authority
More Information
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Responsible Party: Dr. Mark Bloch, Dr Mark Bloch, Holdsworth House Medical Practice
ClinicalTrials.gov Identifier: NCT01154543    
Other Study ID Numbers: Famvir™ 500 in HIV
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: March 20, 2013
Last Verified: March 2013
Keywords provided by Dr. Mark Bloch, Holdsworth House Medical Practice:
Recurrent genital Herpes Simplex Virus
Additional relevant MeSH terms:
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HIV Seropositivity
Herpes Simplex
Herpes Genitalis
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
 Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases