Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008795

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00008795
  •   2015/07/08
  •   2006/08/16
  •   yes
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Secondary IDs

  •   NCT00365729  (ClinicalTrials.gov)
  •   01 KI 0211  (Deutsche Luft und Raumfahrt)
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Health Condition or Problem studied

  •   HIV Infections
  •   Papillomavirus Infections
  •   Anal Intraepithelial Neoplasia
  •   B24 -  Unspecified human immunodeficiency virus [HIV] disease
  •   A63 -  Other predominantly sexually transmitted diseases, not elsewhere classified
  •   K62 -  Other diseases of anus and rectum
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Interventions/Observational Groups

  •   Behavioral: Smear and biopsy testing for HPV-types and viral load
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

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Secondary Outcome

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2003/10/31
  •   1000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- HIV-infected patients

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Exclusion Criteria

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Addresses

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    • Deutsche Luft und Raumfahrt
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    • Department of Dermatology, Ruhr University Bochum
    • Norbert H Brockmeyer, MD 
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    • Norbert H Brockmeyer, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

  •   Kreuter A, Reimann G, Esser S, Rasokat H, Hartmann M, Swoboda J, Conant MA, Tschachler E, Arasteh K, Altmeyer P, Brockmeyer NH. [Screening and therapy of anal intraepithelial neoplasia (AIN) and anal carcinoma in patients with HIV-infection]. Dtsch Med Wochenschr. 2003 Sep 19;128(38):1957-62. Review. German.; 14502448
  •   Kreuter A, Brockmeyer NH, Hochdorfer B, Weissenborn SJ, Stücker M, Swoboda J, Altmeyer P, Pfister H, Wieland U. Clinical spectrum and virologic characteristics of anal intraepithelial neoplasia in HIV infection. J Am Acad Dermatol. 2005 Apr;52(4):603-8.; 15793509
  •   Kreuter A, Hochdorfer B, Stücker M, Altmeyer P, Weiland U, Conant MA, Brockmeyer NH. Treatment of anal intraepithelial neoplasia in patients with acquired HIV with imiquimod 5% cream. J Am Acad Dermatol. 2004 Jun;50(6):980-1.; 15153912
  •   Kreuter A, Brockmeyer NH, Weissenborn SJ, Wafaisade A, Pfister H, Altmeyer P, Wieland U; German Competence Network HIV/AIDS. 5% imiquimod suppositories decrease the DNA load of intra-anal HPV types 6 and 11 in HIV-infected men after surgical ablation of condylomata acuminata. Arch Dermatol. 2006 Feb;142(2):243-4.; 16490857
  •   Kreuter A, Wieland U, Brockmeyer N. [Anal carcinoma and anal intraepithelial neoplasia in HIV-infections]. J Dtsch Dermatol Ges. 2006 Jul;4(7):611-2. German.; 16883662
  •   Kreuter A, Brockmeyer NH, Pfister H, Altmeyer P, Wieland U; Competence Network HIV/AIDS. Human papillomavirus type 26-associated periungual squamous cell carcinoma in situ in a HIV-infected patient with concomitant penile and anal intraepithelial neoplasia. J Am Acad Dermatol. 2005 Oct;53(4):737-9.; 16198810
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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   41
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.