Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Holdsworth House Medical Practice.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Holdsworth House Medical Practice
Information provided by:
Holdsworth House Medical Practice
ClinicalTrials.gov Identifier:
NCT01154543
First received: June 30, 2010
Last updated: NA
Last verified: May 2009
History: No changes posted
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To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects.
Condition |
---|
HIV Positive Herpes Simplex, Genital |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
complement factor I deficiency
Drug Information available for:
Famciclovir
U.S. FDA Resources
Further study details as provided by Holdsworth House Medical Practice:
Estimated Enrollment: | 50 |
Study Start Date: | March 2008 |
Groups/Cohorts |
---|
HIV positive, gential HSV,Famvir™ 500mg bd, suppressive |
![](https://webarchive.library.unt.edu/web/20130312224953im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
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
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No Contacts or Locations Provided
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No publications provided
Responsible Party: | Dr Mark Bloch, Holdsworth House Medical Practice |
ClinicalTrials.gov Identifier: | NCT01154543 History of Changes |
Other Study ID Numbers: | Famvir™ 500 in HIV |
Study First Received: | June 30, 2010 |
Last Updated: | June 30, 2010 |
Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by Holdsworth House Medical Practice:
Recurrent genital Herpes Simplex Virus |
Additional relevant MeSH terms:
Herpes Genitalis Herpes Simplex HIV Seropositivity Herpesviridae Infections DNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Genital Diseases, Male Genital Diseases, Female Skin Diseases, Viral Skin Diseases, Infectious |
Skin Diseases HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Immunologic Deficiency Syndromes Immune System Diseases Famciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013