HPV in Adolescents
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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 |
- 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
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
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| Thailand | |
| HIV-NAT | |
| Bangkok, Thailand, 10330 | |
| Thai Red Cross - Anonymous Clinc | |
| Bangkok, Thailand, 10330 | |
| Department of Pediatrics, Chulalongkorn University | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jintanat Ananworanich, MD., Ph.D., 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: | February 8, 2013 |
| 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 |
Additional relevant MeSH terms:
|
Carcinoma in Situ Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on February 26, 2013
