HIV InfectionsCTNGNCT00973466
Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients
An observational study of HIV Infections and Neisseria Gonorrhoeae, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections, Neisseria Gonorrhoeae, Chlamydia Trachomatis
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2009to Jun 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive HIV-infected patients attending the Clinic for Infectious Diseases at Bern University Hospital will be asked to participate in the study if they were sexually active during the last 12 months
Who may be able to join
- HIV-infection
- Attending the Clinic for Infectious Diseases from May 09 to November 09
- Sexually active during the last 12 months
- Written informed consent
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Infectious Diseases, Berne University Hospital
Bern, 3010
About this study
Official title: Prevalence of Asymptomatic and Symptomatic Infection of N. Gonorrheae and C. Trachomatis and Seroprevalence of HSV Typ 2 and Sexual Health Seeking Behaviour in People With HIV Infection in Bern
There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.
Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals.
- Keywords
- HIV-infection, Neisseria gonorrhea, Chlamydia trachomatis, Herpes simplex virus, prevalence
- Medical subject headings
- HIV Infections, Herpes Simplex, Acquired Immunodeficiency Syndrome
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-infection | All HIV-infected patients attending the Clinic for Infectious Diseases at Berne university hospital, having been sexually active during the past 12 months and having given written informed consent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Merck Sharp & Dohme LLC
- Investigators
- Hansjakob Furrer, MD, Principal investigator, University Hospital Berne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973466
- Sponsor's protocol ID
- KEK26/09
- Acronym
- CTNG
- Status last verified
- Jan 2011
- First submitted
- 4 Sep 2009
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic and Symptomatic Infection of N. Gonorrheae and C. Trachomatis and Seroprevalence of HSV Typ 2 and Sexual Health Seeking Behaviour in People With HIV Infection in Bern
- ClinicalTrials.gov ID
- NCT00973466
- Acronym / sponsor ID
- CTNG / KEK26/09
- Keywords
- HIV-infection, Neisseria gonorrhea, Chlamydia trachomatis, Herpes simplex virus, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Pfizer, Merck Sharp & Dohme LLC
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Sep 2009 (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.
There has been an increase in incidence in sexually transmitted infections in HIV infected patients in the last years. In this study the investigators will prospectively evaluate the prevalence of symptomatic and asymptomatic infections with N. gonorrhea and Ch. trachomatis as well as the seroprevalence of Herpes simplex Type 2 infection in HIV-infected patients attending the clinic for infectious diseases at the Berne University Hospital. In addition, participants will be asked to fill out a questionnaire on sexual behaviour and sexual health.
Study hypothesis: STI prevalence is high in certain risk-groups to justify screening in regular intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV-infection | – | –All HIV-infected patients attending the Clinic for Infectious Diseases at Berne university hospital, having been sexually active during the past 12 months and having given written informed consent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive HIV-infected patients attending the Clinic for Infectious Diseases at Bern University Hospital will be asked to participate in the study if they were sexually active during the last 12 months
Key inclusion criteria (4 listed)
- HIV-infection
- Attending the Clinic for Infectious Diseases from May 09 to November 09
- Sexually active during the last 12 months
- Written informed consent
Key exclusion criteria (1 listed)
- None
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
Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection
Time frame: 6 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 13 Jan 2011.
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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.
Hansjakob Furrer, MD principal investigator
University Hospital Berne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Neisseria Gonorrhoeae, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 4 inclusion and 1 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 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection (time frame: 6 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 13 Jan 2011.