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

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 - ASTIH

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00005468

Enrollment

180

Registered

2013-11-20

Start date

2013-11-22

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B24 B18.2 B17.1 K62.8

Interventions

Group 1: 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 im

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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

Germany

Contacts

Public ContactJulian Storim

Universitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie

julian.storim@uk-essen.de0201-7233696

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 24, 2026