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

NCT ID: NCT01154543

Last Updated: 2013-03-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-02-28

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holdsworth House Medical Practice

OTHER

Sponsor Role: lead

Responsible Party

Dr. Mark Bloch

Dr Mark Bloch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark T Bloch, MBBS

Role: PRINCIPAL_INVESTIGATOR

Australian Health Practitioners Regulation authority

Other Identifiers

Famvir™ 500 in HIV

Identifier Type: -

Identifier Source: org_study_id