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

This study is currently recruiting participants.
Verified February 2014 by Deutsche Luft und Raumfahrt
Sponsor:
Information provided by (Responsible Party):
Alexander Kreuter, Deutsche Luft und Raumfahrt
ClinicalTrials.gov Identifier:
NCT00365729
First received: August 16, 2006
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
HIV Infections
Papillomavirus Infections
Anal Intraepithelial Neoplasia
Behavioral: Smear and biopsy testing for HPV-types and viral load

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluation of Viral Load Determination and Other Biomarkers of High Risk HPV-Types as a Marker for Progression of Perianal HPV-infections in HIV-positive Men Who Have Sex With Men

Resource links provided by NLM:


Further study details as provided by Deutsche Luft und Raumfahrt:

Biospecimen Retention:   Samples With DNA

Anogenital smears


Estimated Enrollment: 1000
Study Start Date: October 2003
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Smear and biopsy testing for HPV-types and viral load
    Smear and biopsy testing for HPV-types and viral load
Detailed Description:

Compared to the general population the incidence of anal intraepithelial neoplasia (AIN) and anal carcinoma (AC) amongst men who have sex with men (MSM) is extremely high (above 70/100,000). While many opportunistic infections have declined since the introduction of highly active antiretroviral therapy (HAART), the incidence of AC has not fallen. In contrast, the HAART-related improvement of survival seems to result in an increased risk of AC in HIV-infected MSM. Screening for cervical intraepithelial neoplasia (CIN) with cervical cytology and early treatment has resulted in a significant decline in the incidence of cervical carcinoma. Like cervical cancer, AC may be preventable through identification and treatment of its precursors. Nevertheless, there has never been an effort to implement an anal cytology screening program for HIV-infected MSM. Persistent cervical infection with high-risk HPV-types is indicative for the development of CIN and cervical cancer. As the prevalence of genital HPV-infections in HIV-infected women and men is very high (up to > 90%), the predictive value of qualitative HPV-DNA detection is limited for cervical cancer or AC prevention. However, several studies have shown that the number of HPV-DNA copies in cervical scrapes may be predictive of the severity of underlying cervical dysplasia. 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. Besides, HPV-E6/E7-oncogen-expression using RT-PCR will be determined. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

HIV-positive men who have sex with men

Criteria

Inclusion Criteria:

  • HIV-infected patients

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00365729

Contacts
Contact: Norbert H Brockmeyer, MD 0049-234-509-3474 n.brockmeyer@derma.de
Contact: Alexander Kreuter, MD 0049-234-509-3439 a.kreuter@derma.de

Locations
Germany
Department of Dermatology, Ruhr University Bochum Recruiting
Bochum, NRW, Germany, 44791
Contact: Alexander Kreuter, MD    0049-234-509-3439    a.kreuter@derma.de   
Sub-Investigator: Alexander Kreuter, MD         
Principal Investigator: Norbert H Brockmeyer, MD         
Institute of Virology Recruiting
Köln, NRW, Germany, 50935
Contact: Ulrike Wieland, MD    0049-221-4783910    ulrike.wieland@uni-koeln.de   
Principal Investigator: Ulrike Wieland, MD         
Sponsors and Collaborators
Deutsche Luft und Raumfahrt
Investigators
Principal Investigator: Norbert H Brockmeyer, MD Department of Dermatology, Ruhr University Bochum
Principal Investigator: Alexander Kreuter, MD Department of Dermatology, Ruhr University Bochum
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexander Kreuter, Prof. Dr., Deutsche Luft und Raumfahrt
ClinicalTrials.gov Identifier: NCT00365729     History of Changes
Other Study ID Numbers: 01 KI 0211
Study First Received: August 16, 2006
Last Updated: February 5, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Deutsche Luft und Raumfahrt:
genitoanal HPV infection
HIV infection

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Neoplasms
HIV Seropositivity
Carcinoma in Situ
Papillomavirus Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
DNA Virus Infections
Tumor Virus Infections

ClinicalTrials.gov processed this record on April 22, 2014