B23 B18.2
Conditions
Interventions
Group 1: 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.
Group 2
Sponsors
Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen, Justus-Liebig-Universität Gießen
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with HIV infection and/or hepatitis C infection with or without antiviral therapy
Exclusion criteria
Exclusion criteria: - altered antiretroviral therapy during the last 12 weeks - non-compliance - reduced cognitive abilities to concieve the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| • 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) | — |
Countries
Germany
Contacts
Public ContactAdrian Pilatz
Klinik und Poliklinik für Urologie, Kinderurologie und Andrologie, Universitätsklinikum Gießen und Marburg GmbH, Standort Gießen , Justus-Liebig-Universität Gießen
Outcome results
None listed