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Viral Load Determination and Biomarkers of High Risk Human Papillomavirus (HPV) - Types in HIV-positive Men

NCT00365729 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2016-01-21

No results posted yet for this study

Summary

Human papillomavirus (HPV)-infection belongs to the most common sexually transmitted diseases worldwide. HIV-infected men having sex with men (MSM) are strongly associated with a higher prevalence of genital HPV-infection, a higher incidence of anal intraepithelial neoplasia (AIN), and, consecutively, an increased risk for anal cancer. Since the introduction of highly active antiretroviral therapy (HAART), the incidence of several viral-associated neoplasias has significantly fallen in HIV-infected individuals. At the beginning of the era of HAART, a justified hope existed that genitoanal HPV-related neoplasias would also decrease based on the success of HAART-induced immune restoration. However, HAART seems to have only a small impact on the natural history of AIN as observed in a cohort of HIV-positive MSM before and after the initiation of HAART.

As AIN and cancer precursor lesions of the cervix, cervical intraepithelial neoplasia, share distinct clinical similarities, cytologic smear testing for AIN has been recommended to detect and treat early lesions. Thus, this prospective study mainly focuses on the predictive value of HPV-DNA load for the development and clinical progression of AIN in HIV-infected MSM. Moreover, the course of HPV viral load under therapy for anal intraepithelial neoplasia, e.g. topical treatment with imiquimod, will be evaluated. Additionally, immunohistochemical determination of several proliferative biomarkers, as well as cytokines, will be performed.

Conditions

  • HIV Infections
  • Papillomavirus Infections
  • Anal Intraepithelial Neoplasia

Interventions

BEHAVIORAL

Smear and biopsy testing for HPV-types and viral load

Smear and biopsy testing for HPV-types and viral load

Sponsors & Collaborators

  • Deutsche Luft und Raumfahrt

    lead OTHER_GOV

Principal Investigators

  • Norbert H Brockmeyer, MD · Department of Dermatology, Ruhr University Bochum

  • Alexander Kreuter, MD · Department of Dermatology, Ruhr University Bochum

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2017-01-31
Completion
2018-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365729 on ClinicalTrials.gov