Trial document




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  DRKS00005468

Trial Description

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Title

Influence of concomitant anal sexual transmitted infections (bacterial proctitis and HPV infections) and of HIV/Hepatitis C-Co-Infections on anal secretion of HIV and Hepatitis C viruses, respectively

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Trial Acronym

ASTIH

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Despite broad usage of highly active therapies against HIV (“antiretroviral therapy”, ART) the number of newly diagnosed HIV-infections amongst men how have sex with men (MSM, mainly homo- or bisexual men) in Germany nearly doubled from 2003 to 2012. In contrast, within the same time span the number of newly diagnosed HIV-infections in other population groups remained unchanged or even decreased. One reason for this discrepancy is the higher distribution of other sexually transmitted infections amongst MSM. For example, the risk to become HIV-infected is increased for HIV-negative MSM who suffer from an anal sexually transmitted infections. Additionally, a concomitant sexually transmitted infection may increase the amount of HIV in the semen of HIV-positive men and may therefore increase their infectiousness. The first aim of this study is to analyse whether anal sexually transmitted infections also increase the anal secretion of HIV. Additionally, potential mechanisms of an increased anal HIV-secretion will be addressed. Sexually active HIV-positive MSM may participate in this arm of the study. While sexual transmission of Hepatitis C was rare in the past, the number of sexually transmitted Hepatitis C virus infections amongst HIV-positive MSM increased during the last years. Increased Hepatitis C-infectiousness of HIV/Hepatitis C-co-infected individuals might be one possible explanation. The second aim of this study is to analyse whether HIV/Hepatitis C-co-infected individuals secrete more Hepatitis C Viruses anally than Hepatitis C-monoinfected individuals. HIV/Hepatitis C-co-infected and Hepatitis C-monoinfected individuals may participate in this arm of the study.

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Brief Summary in Scientific Language

In serodiscordant heterosexual couples, treatment of the HIV-positive partner prevents HIV-transmission reliably. However, between 2003 and 2012 the number of newly diagnosed HIV-infections amongst men who have sex with men (MSM) in Germany nearly doubled despite the broad usage of antiretroviral therapy (ART). One reason for this discrepancy is the higher prevalence of (mostly asymptomatic) anal sexually transmitted infections (STI) with Neisseria gonorrhoeae, Chlamydia trachomatis and human Papillomaviruses (HPV). All of these STI increase HIV-susceptibility. Additionally, anal STI might increase the anal secretion - and therefore HIV-infectiousness - of HIV-infected individuals. Indeed, a concomitant urethritis increases genital shedding of HIV.

Sexual transmission of Heaptitis C virus (HCV) amongst HIV-positive MSM increased during the last years. Potential biological reasons – e.g. higher HCV-infectiousness of HIV/HCV-Co-infected individuals – are unknown.

The main questions addressed by this study are:
1. Is anal Shedding of HIV increased by bacterial proctitis and/or anal infections with HPV?
2. What are the underlying mechanisms?
3. Is anal Shedding of HCV increased in HIV/HCV-Co-infected individuals?

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Organizational Data

  •   DRKS00005468
  •   2013/11/20
  •   [---]*
  •   yes
  •   Approved
  •   13-5650-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

  •   U1111-1150-4804 
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Health Condition or Problem studied

  •   B24 -  Unspecified human immunodeficiency virus [HIV] disease
  •   B18.2 -  Chronic viral hepatitis C
  •   B17.1 -  Acute hepatitis C
  •   K62.8 -  Other specified diseases of anus and rectum
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Interventions/Observational Groups

  •   One single visit, HIV-positive men who have sex with men: 1. patient record/medical history: HIV-state, Date of HIV-Diagnosis, antiretroviral therapy yes/no, nicotine abuse, use of topical imiquimod yes/no. 2. Blood analyses: HIV-RNA (blood), CD4+ T-lymphocytes, CRP, Syphilis-Serology. 3. Anal swabs: HIV-RNA (anal secretion), Gonorrhoea/Chlamydia-PCR, HPV-Type analysis, cytology. 4. Proctological examination via “high-resolution anoscopy”.
  •   One single visit, HIV/Hepatitis C-Co-infected individuals: 1. patient record/medical history: HIV-state, Date of HIV-Diagnosis, ART yes/no, nicotine abuse, Hepatitis C virus genotype, Date of Hepatitis C diagnosis. 2. Blood analyses: HIV-RNA (blood), CD4+ T-lymphocytes, CRP, Hepatitis C-RNA (blood). 3. Anal swabs: Hepatitis C-RNA (anal secretion)
  •   One single visit, HCV-monoinfected individuals: 1. patient record/medical history: HIV-state, Date of HIV-Diagnosis, ART yes/no, nicotine abuse, Hepatitis C virus genotype, Date of Hepatitis C diagnosis. 2. Blood analyses: HIV-RNA (blood), CD4+ T-lymphocytes, CRP, Hepatitis C-RNA (blood). 3. Anal swabs: HCV-RNA (anal secretion)
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Characteristics

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

1. Amount of anally secreted HIV-RNA in relation to plasma concentration of HIV-RNA in Men who have sex with men a) without anal sexually transmitted infections, b) with concomitant bacterial proctitis, and c) with concomitant anal HPV-infection. Anally secreted HIV-RNA will be measured semiquantitatively via PCR, results will be expressed as copies/swab
2. Amount of anally secreted Hepatitis C-RNA in relation to plasma concentration of Hepatitis C-RNA in a) HIV/Hepatitis C-Co-infected individuals, and b) Hepatitis C-monoinfected individuals. Anally secreted Hepatitis C-RNA will be measured semiquantitatively via PCR, results will be expressed as copies/swab.

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Secondary Outcome

1. Effect of anal inflammatory cells on anally secreted HIV-RNA (semiquantitative measurement of inflammatory cells via cytological swab).
2. Correlation of subjective symptoms with anally secreted HIV-RNA (medical history).
3. Correlation of protological examination with anally secreted HIV-RNA.
4. Effect of HIV-state and current concentration of CD4+ T lymphocyte count on anally secreted HIV-RNA and HCV-RNA, respectively.
5. Effect of smoking on anally secreted HIV-RNA and HCV-RNA, respectively.
6. Effect of HIV-RNA plasma concentration on anally secreted HCV-RNA.
7. Effect of topical Imiquimod on anally secreted HIV-RNA.
8. Effect of Syphilis on anally secreted HIV-RNA.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/11/22
  •   180
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Arm 1: 1. MSM; 2. confirmed HIV-infection; 3. signed ICF.
Arm 2: 1. confirmed HIV/HCV-co-infectionen; 2. signed ICF.
Arm 3: 1. confirmed HCV-monoinfection with excluded HIV-infection; 2. signed ICF.

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Exclusion Criteria

none

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Addresses

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    • Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie
    • Mr.  Dr. med.  Stefan  Esser 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie
    • Mr.  Dr. med. Dr. rer. nat.  Julian  Storim 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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    • Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie
    • Mr.  Dr. med. Dr. rer. nat.  Julian  Storim 
    • Hufelandstr. 55
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Gesundheit
    • 53107  Bonn
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting stopped after recruiting started
  •   2014/02/28
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Trial Publications, Results and other Documents

  •   accepted for publication: Storim J, Verheyen J, Wolff E, et al. Sex Transm Infect Epub ahead of print. doi:10.1136/sextrans-2017-053409
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* This entry means the parameter is not applicable or has not been set.