HPV in Adolescents

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01788852

First Posted: February 11, 2013

Last Update Posted: April 1, 2015

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.

Collaborators:

Thai Red Cross AIDS Research Centre

Chulalongkorn University

South East Asia Research Collaboration with Hawaii

We Understand Group

TREAT Asia

Information provided by (Responsible Party):

The HIV Netherlands Australia Thailand Research Collaboration

Purpose

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

Condition
HPV Infection Cervical/Anal Dysplasia


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by The HIV Netherlands Australia Thailand Research Collaboration:

Primary Outcome Measures:

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 Outcome Measures:

intraepithelial neoplasia [ Time Frame: 48 weeks ]
Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects
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
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)

Biospecimen Retention: Samples With DNA

Cervical and anal pap smears specimens will be used for HPV typing. Blood will be collected for STI and immune response to HPV/HIV testing


Enrollment:	27
Study Start Date:	December 2010
Study Completion Date:	December 2012
Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Perinatally HIV-infected adolescents Perinatally HIV-infected adolescents
behaviorally HIV-infected adolescents behaviorally HIV-infected adolescents
HIV negative adolescents HIV negative adolescents

Detailed 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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Years to 24 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

A total of 60 sexually active adolescents (perinatally and behaviorally HIV-infected adolescents, HIV negative adolescents) aged 12-24 will be recruited from the HIV-NAT and TRC Anonymous Clinic

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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): NCT01788852

Locations


Thailand
Department of Pediatrics, Chulalongkorn University
Bangkok, Thailand, 10330
HIV-NAT
Bangkok, Thailand, 10330
Thai Red Cross - Anonymous Clinc
Bangkok, Thailand, 10330

Sponsors and Collaborators

The HIV Netherlands Australia Thailand Research Collaboration

Thai Red Cross AIDS Research Centre

Chulalongkorn University

South East Asia Research Collaboration with Hawaii

We Understand Group

TREAT Asia

Investigators


Principal Investigator:	Jintanat Ananworanich, MD, PhD	The HIV Netherlands Australia Thailand Research Collaboration
Principal Investigator:	Nittaya Phanuphak, MD	Thai Red Cross AIDS Research Centre

More Information

Additional Information:

HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s website This link exits the ClinicalTrials.gov site


Responsible Party:	The HIV Netherlands Australia Thailand Research Collaboration
ClinicalTrials.gov Identifier:	NCT01788852 History of Changes
Other Study ID Numbers:	HIV-NAT 139
First Submitted:	February 7, 2013
First Posted:	February 11, 2013
Last Update Posted:	April 1, 2015
Last Verified:	March 2015

Keywords provided by The HIV Netherlands Australia Thailand Research Collaboration:


HPV HIV cervical/anal dysplasia intraepithelial neoplasia	E6/E7 biomarker perinatally HIV-infected adolescents behaviorally HIV-infected adolescents anal and pap smear

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