Skip to main content
OpenTrials
Completed

NCT Number: NCT01788852

HPV in Adolescents

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

HPV Infection Carcinoma Carcinoma in Situ Cervical/Anal Dysplasia Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

12 year–24 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics, Chulalongkorn University, Bangkok, Thailand

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. HPV infection

    Time frame: 48 weeks

    Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents

Secondary outcomes

  1. intraepithelial neoplasia

    Time frame: 48 weeks

    Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects

  2. E6/E7

    Time frame: 48 weeks

    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

  3. HPV vaccine

    Time frame: 48 weeks

    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)

Sponsors and collaborators

Lead sponsor

The HIV Netherlands Australia Thailand Research Collaboration

Other

Collaborators

  • Chulalongkorn University
  • SEARCH Research Foundation
  • TREAT Asia
  • Thai Red Cross AIDS Research Centre
  • We Understand Group

Registry information

Official study title

Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2013
Registry last updated
Apr 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.