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

• Conditions: B24; B18.2; B17.1; K62.8; Unspecified human immunodeficiency virus [HIV] disease; Chronic viral hepatitis C; Acute hepatitis C; Other specified diseases of anus and rectum

• Registration Number: DRKS00005468
• Lead Sponsor: niversitätsklinikum Essen, Klinik für Dermatologie, Venerologie und Allergologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-20
• Study Completion: 2014-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 112

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

none

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>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.<br>

Secondary Outcome Measures

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