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HPV in Adolescents

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01788852
First received: February 7, 2013
Last updated: March 30, 2015
Last verified: March 2015
History of Changes
  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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects

  • E6/E7 [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
    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
Ages Eligible for Study:   12 Years to 24 Years   (Child, Adult)
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: February 7, 2013
Last Updated: March 30, 2015
Health Authority: Thailand: Ethical Committee

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

ClinicalTrials.gov processed this record on September 28, 2016