HPV in Adolescents

HPV Infection Clinical Trial

Official title:

Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01788852
• Other study ID #: HIV-NAT 139
• Status: Completed
• Phase: N/A
• First received: February 7, 2013
• Last updated: March 30, 2015
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: The HIV Netherlands Australia Thailand Research Collaboration
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Observational

Clinical Trial Summary

This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.

Description:

Human Papillomavirus (HPV) is the most common sexually transmitted disease and it causes cervical and anal cancer. Prevalence and incidence of HPV infection among young adults who are sexually experienced is high. No data exist for HIV-positive adolescents in regards to HPV infection, cervical and anal intraepithelial neoplasia. This study will compare the prevalence of HPV infection, intraepithelial neoplasia and E6/E7 biomarker at cervical and anal sites among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIV-negative adolescents.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 24 Years

Eligibility

Inclusion Criteria:

• Perinatally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time and history of maternal HIV infection)

• behaviorally-infected (documented positive HIV enzyme immunoassay (EIA) or nucleic acid testing (NAT) at any time after sexual debut without history of maternal HIV infection)

• female with vaginal or receptive anal intercourse with a male OR male with receptive rectal intercourse with another male

• Signed informed consent. Volunteers aged 12-17 years can decide whether they wish for their parents to consent for their participation. Due to the confidential nature of the issues being studied, parental consent may be exempted

Exclusion Criteria:

• Have any conditions that may interfer with subjects' ability to understand and consent to the study

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical/Anal Dysplasia
• HPV Infection

Locations

Country	Name	City	State
Thailand	Department of Pediatrics, Chulalongkorn University	Bangkok
Thailand	HIV-NAT	Bangkok
Thailand	Thai Red Cross - Anonymous Clinc	Bangkok

Sponsors (6)

Lead Sponsor	Collaborator
The HIV Netherlands Australia Thailand Research Collaboration	Chulalongkorn University, South East Asia Research Collaboration with Hawaii, Thai Red Cross AIDS Research Centre, TREAT Asia, We Understand Group

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV infection	Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents	48 weeks	Yes
Secondary	intraepithelial neoplasia	Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects	48 weeks	Yes
Secondary	E6/E7	Prevalence of detected E6/E7 biomarker among the tree study groups and in male and female subjects.; Correlation between detected E6/E7 and presence of HPV infection and/or intraepithelial neoplasia Association between HAART use, CD4 counts, plasma HIV RNA level and HIV clinical staging with HPV infection, intraepithelial neoplasia and E6/E7 detection	48 weeks	Yes
Secondary	HPV vaccine	Proportion of adolescents who would benefit from the current preventive vaccine (i.e. those who have not been infected with oncogenic HPV subtypes 16 and 18)	48 weeks	No

External Links

•   HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website