Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00365729
Status:
UNKNOWN
Last Update Posted:
2016-01-21
First Post:
2006-08-16
Brief Title:
Viral Load Determination and Biomarkers of High Risk Human Papillomavirus HPV - Types in HIV-positive Men
Sponsor:
Deutsche Luft und Raumfahrt
Organization:
Deutsche Luft und Raumfahrt
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2016-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 eg topical treatment with imiquimod will be evaluated Additionally immunohistochemical determination of several proliferative biomarkers as well as cytokines will be performed
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 eg topical treatment with imiquimod will be evaluated Additionally immunohistochemical determination of several proliferative biomarkers as well as cytokines will be performed
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 70100000 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-E6E7-oncogen-expression using RT-polymerase chain reaction RT-PCR will be determined Moreover the course of HPV viral load under therapy for anal intraepithelial neoplasia eg topical treatment with imiquimod will be evaluated Additionally immunohistochemical determination of several proliferative biomarkers as well as cytokines will be performed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None