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

NCT01154543 | Completed

• 1 other identifier: Famvir™ 500 in HIV
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Positive; Herpes Simplex, Genital

Keywords

Recurrent genital Herpes Simplex Virus

Outcome Measures

Primary Outcomes (1)

• To determine the incidence of acute genital HSV outbreaks whilst taking Famciclovir 500 mg bd during the study period (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

  24 months

Secondary Outcomes (1)

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

  24 months

Study Arms (1)

HIV positive, gential HSV,Famvir™ 500mg bd, suppressive

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Holdsworth House Medical Practice: lead

MeSH Terms

Conditions

HIV Seropositivity; Herpes Genitalis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Herpes Simplex; Herpesviridae Infections; DNA Virus Infections; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Male; Male Urogenital Diseases

Study Officials

• Mark T Bloch, MBBS

  Australian Health Practitioners Regulation authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Mark Bloch

Study Record Dates

• First Submitted: June 30, 2010
• First Posted: July 1, 2010
• Study Start: March 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03