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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
History of Changes

June 30, 2010
March 19, 2013
March 2008
January 2013   (final data collection date for primary outcome measure)
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
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Complete list of historical versions of study NCT01154543 on ClinicalTrials.gov Archive Site
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
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Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes
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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
  • HIV Positive
  • Herpes Simplex, Genital
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HIV positive, gential HSV,Famvir™ 500mg bd, suppressive
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
February 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01154543
Famvir™ 500 in HIV
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Dr. Mark Bloch, Holdsworth House Medical Practice
Holdsworth House Medical Practice
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Principal Investigator: Mark T Bloch, MBBS Australian Health Practitioners Regulation authority
Holdsworth House Medical Practice
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP