Viral Load Determination and Biomarkers of High Risk Human Papillomavirus (HPV) - Types in HIV-positive Men
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00365729 |
Recruitment Status
: Unknown
Verified January 2016 by Alexander Kreuter, Deutsche Luft und Raumfahrt.
Recruitment status was: Recruiting
First Posted
: August 17, 2006
Last Update Posted
: January 21, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment |
---|---|
HIV Infections Papillomavirus Infections Anal Intraepithelial Neoplasia | Behavioral: Smear and biopsy testing for HPV-types and viral load |
Study Type : | Observational |
Estimated Enrollment : | 1000 participants |
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 |
Study Start Date : | October 2003 |
Estimated Primary Completion Date : | January 2017 |
Estimated Study Completion Date : | January 2018 |

-
Behavioral: Smear and biopsy testing for HPV-types and viral load
- Spectrum of HPV types, HPV viral loads, and associated clinical lesions [ Time Frame: swabs will be obtained approximately every 6 months ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- HIV-infected patients
Exclusion Criteria:

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365729
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 | |
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 |
Principal Investigator: | Norbert H Brockmeyer, MD | Department of Dermatology, Ruhr University Bochum | |
Principal Investigator: | Alexander Kreuter, MD | Department of Dermatology, Ruhr University Bochum |
Publications of Results:
Other Publications:
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 |
First Posted: | August 17, 2006 Key Record Dates |
Last Update Posted: | January 21, 2016 |
Last Verified: | January 2016 |
Keywords provided by Alexander Kreuter, Deutsche Luft und Raumfahrt:
genitoanal HPV infection HIV infection |
Additional relevant MeSH terms:
Infection Communicable Diseases HIV Infections 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 Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms DNA Virus Infections Tumor Virus Infections |