Trial document





This trial has been registered retrospectively.
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  DRKS00003475

Trial Description

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Title

Chronic HIV infection, male hypogonadism, sexual dysfunction and fertility

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Trial Acronym

LOEWE MIBIE B2

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The focus of this study is to investigate the impact of HIV and/or hepatitis C on the gonadal function. In this context possible associations between the general medical condition, viral load, messengers of inflammation, sex hormones, and semen quality will be investigated.

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Brief Summary in Scientific Language

In this project the andrological status of HIV patients is investigated and compared to patients with hepatitis C infection. This study investigates the andrologic findings and the viral status in parallel to the usual medical care for infectious patients for a time period of 12 months. The matter of subject is the gonadal function (sexual hormones, spermatogenesis/semen) dependent on the viral status. The main focus ist the investigation of possible associations between viral infection, inflammation, and gonadal function.

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Organizational Data

  •   DRKS00003475
  •   2012/01/09
  •   [---]*
  •   yes
  •   Approved
  •   111/11, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   B23 -  Human immunodeficiency virus [HIV] disease resulting in other conditions
  •   B18.2 -  Chronic viral hepatitis C
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Interventions/Observational Groups

  •   patients with HIV infection - investigation of the gonadal function and viral status at baseline and after 6 and 12 months parallel to the usual medical care for infectious patients.
  •   patients with hepatitis C infection - investigation of the gonadal function and viral status at baseline and after 6 and 12 months parallel to the usual medical care for infectious patients.
  •   patients with HIV and hepatitis C infection - investigation of the gonadal function and viral status at baseline and after 6 and 12 months parallel to the usual medical care for infectious patients.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

• Impact of HIV compared to hepatitis C on the gonadal function (sexual hormones: FSH, LH, inhibin, testesterone, oestradiol, prolactin; semen quality: semen analysis according WHO 1999 and WHO 2010 classification) with follow-up visits after 6 and 12 months

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Secondary Outcome

• determine and compare the viral load in blood and semen
• determine the prevalence of hypogonadism
• determine differences between patients with HIV and hepatitis C
• investigate the impact of surrogate parameters (CD4 cell count, duration of HIV infection) on gonadal function
• investigate the impact of antiviral therapy on gonadal function
• determine inflammatory parameters in the male genitourinary tract (2 resp. 4-glas test, leukocytes in urine, PSA in blood, inflammatory parameters in semen: leukocytes, elastase, cytokines)
• investigate an association between inflammation, fertility and viral load
• determine comorbidities (anamnesis, clinical investigation, laboratory parameters, medical reports)
• determine ultrasonographic features of male sex organs (testicular size, epididymal size, perfusion of the spermatic cord, testis, and epididymis, size and echogenity of the prostate)
• determine bladder function (residual urine, IPSS questionnaire)
• determine the impact of the infection on quality of life using questionnaires (NIH-CPSI, CESI, SF-12, HADS-D, HRS)
• investigate the impact of infection on sexual function with standardized interview and questionnaires (NIH-CPSI, IIEF, HRS)
• determine the need for uro-surgical intervention
• investigate risk factors for impaired semen quality
• analyze sperm protein content (proteomics)
• investigate the prevalence of sexual transmitted diseases (Chlamydia, Mycoplasma, Gonorrhoeae)
• determine the benefit of 16 S rRNA gene sequencing for the detection of pathogens in urine and semen
• assess the andrologic health status over a time period of 12 months (baseline, follow-up investigations at 6 and 12 months)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2011/05/24
  •   300
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with HIV infection and/or hepatitis C infection with or without antiviral therapy

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Exclusion Criteria

- altered antiretroviral therapy during the last 12 weeks
- non-compliance
- reduced cognitive abilities to concieve the study

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Addresses

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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Justus-Liebig-Universität Gießen
    • Mr.  Privatdozent Dr. med.  Thorsten  Diemer 
    • Rudolf-Buchheim-Str.7
    • 35392  Gießen
    • Germany
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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Justus-Liebig-Universität Gießen
    • Mr.  Privatdozent  Thorsten  Diemer 
    • Rudolf-Buchheim-Str.7
    • 35392  Gießen
    • Germany
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    • Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen , Justus-Liebig-Universität Gießen
    • Mr.  Dr. med.  Adrian  Pilatz 
    • Rudolf-Buchcheim-Str.7
    • 35392  Gießen
    • Germany
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Sources of Monetary or Material Support

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    • Hessisches Ministerium für Wissenschaft und Kunst, Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz (LOEWE) des Bundeslandes Hessen, Schwerpunkt "Männliche Infertilität bei Infektion & Entzündung" (MIBIE), Projekt B2
    • Rheinstraße 23 - 25
    • 65185  Wiesbaden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.