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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00973466
Other study ID # KEK26/09
Secondary ID
Status Completed
Phase N/A
First received September 4, 2009
Last updated January 12, 2011
Start date May 2009
Est. completion date June 2010

Study information

Verified date January 2011
Source University Hospital Inselspital, Berne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HIV-infection

- Attending the Clinic for Infectious Diseases from May 09 to November 09

- Sexually active during the last 12 months

- Written informed consent

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Switzerland Clinic for Infectious Diseases, Berne University Hospital Bern

Sponsors (3)

Lead Sponsor Collaborator
University Hospital Inselspital, Berne Merck Sharp & Dohme Corp., Pfizer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection 6 months No
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