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Clinical Trials/NCT01154543
NCT01154543CompletedNot Applicable

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.

Holdsworth House Medical Practice0 sites42 target enrollmentStarted: March 2008Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
42
Primary Endpoint
To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (24 months)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy(24 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Mark Bloch

Dr Mark Bloch

Holdsworth House Medical Practice

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