HIV PositiveNCT01154543
Safety and Efficacy of Famciclovir in HIV1 Positive Adults With Recurrent Genital Herpes
An observational study of HIV Positive and Herpes Simplex, Genital, run by Holdsworth House Medical Practice.
Trial summary
To determine the efficacy of Famvir 500mg bd as suppressive antiviral therapy for acute genital Herpes simplex virus (HSV) outbreaks in HIV subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Positive, Herpes Simplex, Genital
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Feb 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
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
- Medical subject headings
- HIV Seropositivity, Herpes Genitalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV positive, gential HSV,Famvir™ 500mg bd, suppressive | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (1)
To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startMar 2008
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV PositiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holdsworth House Medical Practice
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mark Bloch, Holdsworth House Medical Practice
- Investigators
- Mark T Bloch, MBBS, Principal investigator, Australian Health Practitioners Regulation authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01154543
- Sponsor's protocol ID
- Famvir™ 500 in HIV
- Status last verified
- Mar 2013
- First submitted
- 30 Jun 2010
- Last updated
- 20 Mar 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01154543
- Acronym / sponsor ID
- Famvir™ 500 in HIV
- Conditions
- HIV Positive, Herpes Simplex, Genital
- Keywords
- Recurrent genital Herpes Simplex Virus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Holdsworth House Medical PracticeUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV positive, gential HSV,Famvir™ 500mg bd, suppressive | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
To determine the acceptability of Famciclovir 500 mg bd as long term suppressive antiviral therapy
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark T Bloch, MBBS principal investigator
Australian Health Practitioners Regulation authority
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Positive and Herpes Simplex, Genital, run by Holdsworth House Medical Practice.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.