HPV InfectionNCT01788852
HPV in Adolescents
An observational study of HPV Infection and Cervical/Anal Dysplasia, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
Trial summary
This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites. Read more about this study
- Who is it for?
- Ages 12 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Infection, Cervical/Anal Dysplasia
- How many people
- 27 participants
- Where
- 3 sitesThailand
- Study dates
- Dec 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Have any conditions that may interfer with subjects' ability to understand and consent to the study
Trial locations and contacts
3 sites in 1 country.
Thailand3 sites
Department of Pediatrics, Chulalongkorn University
Bangkok, 10330
HIV-NAT
Bangkok, 10330
Thai Red Cross - Anonymous Clinc
Bangkok, 10330
About this study
Official title: Prevalence of HPV and Intraepithelial Neoplasia Biomarkers 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.
Read the 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.
- Conditions
- HPV Infection, Cervical/Anal Dysplasia
- Keywords
- HPV, HIV, cervical/anal dysplasia, intraepithelial neoplasia, E6/E7 biomarker, perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, anal and pap smear
- Medical subject headings
- Papillomavirus Infections, Carcinoma in Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Perinatally HIV-infected adolescents | Perinatally HIV-infected adolescents | |
| behaviorally HIV-infected adolescents | behaviorally HIV-infected adolescents | |
| HIV negative adolescents | HIV negative adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV infection
Prevalence of cervical and anal HPV infection and of oncogenic subtypes, among perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, and HIv-negative adolescents
Measured: 48 weeks
Secondary outcomes (3)
intraepithelial neoplasia
Prevalence of intraepithelial neoplasia among the three study groups and in male and female subjects
Measured: 48 weeks
E6/E7
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
Measured: 48 weeks
HPV vaccine
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)
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startDec 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The HIV Netherlands Australia Thailand Research Collaboration
- Sponsor type
- University, hospital or other
- Collaborators
- Thai Red Cross AIDS Research Centre, Chulalongkorn University, SEARCH Research Foundation, We Understand Group, TREAT Asia
- Responsible party
- Sponsor
- Investigators
- Jintanat Ananworanich, MD, PhD, Principal investigator, The HIV Netherlands Australia Thailand Research CollaborationNittaya Phanuphak, MD, Principal investigator, Thai Red Cross AIDS Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788852
- Sponsor's protocol ID
- HIV-NAT 139
- Status last verified
- Mar 2015
- First submitted
- 7 Feb 2013
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV and Intraepithelial Neoplasia Biomarkers in Adolescents
- ClinicalTrials.gov ID
- NCT01788852
- Acronym / sponsor ID
- HIV-NAT 139
- Conditions
- HPV Infection, Cervical/Anal Dysplasia
- Keywords
- HPV, HIV, cervical/anal dysplasia, intraepithelial neoplasia, E6/E7 biomarker, perinatally HIV-infected adolescents, behaviorally HIV-infected adolescents, anal and pap smear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The HIV Netherlands Australia Thailand Research CollaborationUniversity, hospital or other
- Collaborators
- Thai Red Cross AIDS Research Centre, Chulalongkorn University, SEARCH Research Foundation, We Understand Group, TREAT Asia
- Study start
- Dec 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the prevalence of HPV infection in perinatally HIV-infected adolescents, intraepithelial neoplasia, and E6E7 biomarker at cervical and anal sites.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perinatally HIV-infected adolescents | – | –Perinatally HIV-infected adolescents |
| behaviorally HIV-infected adolescents | – | –behaviorally HIV-infected adolescents |
| HIV negative adolescents | – | –HIV negative adolescents |
Who may qualify
- Ages
- 12 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Have any conditions that may interfer with subjects' ability to understand and consent to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
intraepithelial neoplasia
Time frame: 48 weeks
E6/E7
Time frame: 48 weeks
HPV vaccine
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
- HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT)'s websiteLink provided by the sponsor.
Related trials for HPV Infection
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Active, not recruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jintanat Ananworanich, MD, PhD principal investigator
The HIV Netherlands Australia Thailand Research Collaboration
Nittaya Phanuphak, MD principal investigator
Thai Red Cross AIDS Research Centre
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV Infection and Cervical/Anal Dysplasia, run by The HIV Netherlands Australia Thailand Research Collaboration at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HPV infection (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2015.