HPV in Adolescents
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ClinicalTrials.gov Identifier: NCT01788852 |
Recruitment Status
:
Completed
First Posted
: February 11, 2013
Last Update Posted
: April 1, 2015
|
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Condition or disease |
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HPV Infection Cervical/Anal Dysplasia |
Study Type : | Observational |
Actual Enrollment : | 27 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents |
Study Start Date : | December 2010 |
Actual Primary Completion Date : | December 2012 |
Actual Study Completion Date : | December 2012 |

Group/Cohort |
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Perinatally HIV-infected adolescents
Perinatally HIV-infected adolescents
|
behaviorally HIV-infected adolescents
behaviorally HIV-infected adolescents
|
HIV negative adolescents
HIV negative adolescents
|
- 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
- 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

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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 |
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

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
Thailand | |
Department of Pediatrics, Chulalongkorn University | |
Bangkok, Thailand, 10330 | |
HIV-NAT | |
Bangkok, Thailand, 10330 | |
Thai Red Cross - Anonymous Clinc | |
Bangkok, Thailand, 10330 |
Principal Investigator: | Jintanat Ananworanich, MD, PhD | The HIV Netherlands Australia Thailand Research Collaboration | |
Principal Investigator: | Nittaya Phanuphak, MD | Thai Red Cross AIDS Research Centre |
Additional Information:
Responsible Party: | The HIV Netherlands Australia Thailand Research Collaboration |
ClinicalTrials.gov Identifier: | NCT01788852 History of Changes |
Other Study ID Numbers: |
HIV-NAT 139 |
First Posted: | February 11, 2013 Key Record Dates |
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 |
Additional relevant MeSH terms:
Papillomavirus Infections DNA Virus Infections Virus Diseases Tumor Virus Infections |