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OpenTrials
Completed

NCT Number: NCT01154543

Safety and Efficacy of Famciclovir in HIV1 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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Holdsworth House Medical Practice

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2010
Registry last updated
Mar 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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