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Trial record 1 of 1 for:    NCT00973466
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Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients (CTNG)

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ClinicalTrials.gov Identifier: NCT00973466
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : January 13, 2011
Sponsor:
Collaborators:
Pfizer
Merck Sharp & Dohme Corp.
Information provided by:
University Hospital Inselspital, Berne

Tracking Information
First Submitted Date September 4, 2009
First Posted Date September 9, 2009
Last Update Posted Date January 13, 2011
Study Start Date May 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 7, 2009)
Prevalence of infection with C.trachomatis, N. gonorrhea and Seroprevalence of HSV 2 infection [ Time Frame: 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Sexually Transmitted Infections (STIs) in HIV-infected Patients
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
Brief 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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
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
Condition
  • HIV Infections
  • Neisseria Gonorrhoeae
  • Chlamydia Trachomatis
  • Herpes Simplex
Intervention Not Provided
Study Groups/Cohorts 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: September 7, 2009)
300
Original Estimated Enrollment Same as current
Actual Study Completion Date June 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00973466
Other Study ID Numbers KEK26/09
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hansjakob Furrer, Leitender Arzt, University Hospital Inselspital, Berne
Study Sponsor University Hospital Inselspital, Berne
Collaborators
  • Pfizer
  • Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Hansjakob Furrer, MD University Hospital Berne
PRS Account University Hospital Inselspital, Berne
Verification Date January 2011