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

August 16, 2006
February 5, 2014
October 2003
January 2016   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00365729 on ClinicalTrials.gov Archive Site
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Viral Load Determination and Biomarkers of High Risk Human Papillomavirus (HPV) - Types in HIV-positive Men
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

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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Anogenital smears

Probability Sample

HIV-positive men who have sex with men

  • HIV Infections
  • Papillomavirus Infections
  • Anal Intraepithelial Neoplasia
Behavioral: Smear and biopsy testing for HPV-types and viral load
Smear and biopsy testing for HPV-types and viral load
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
January 2017
January 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV-infected patients

Exclusion Criteria:

  • None
Male
18 Years and older
Yes
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
Germany
 
NCT00365729
01 KI 0211
Not Provided
Alexander Kreuter, Deutsche Luft und Raumfahrt
Deutsche Luft und Raumfahrt
Not Provided
Principal Investigator: Norbert H Brockmeyer, MD Department of Dermatology, Ruhr University Bochum
Principal Investigator: Alexander Kreuter, MD Department of Dermatology, Ruhr University Bochum
Deutsche Luft und Raumfahrt
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP