Human Immunodeficiency VirusGAINNCT03742375
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
A study testing HPV genotyping in people with Human Immunodeficiency Virus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- HPV genotyping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Aug 2018to 1 Nov 2020
- Phase
- Interventional
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
- Referred for high-resolution anoscopy
Who cannot join
- Documented AIN (treated or untreated)
- Local anal inflammation (proctitis) and/or acute fissure
Trial locations and contacts
1 site in 1 country.
About this study
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- HPV genotyping
- Keywords
- Human Papilloma Virus, Anal Intraepithelial Neoplasia
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV genotypingDiagnostic test
Quantitative HPV genotyping on anal swab
| Study group | Role | What they receive |
|---|---|---|
| HPV genotyping | Experimental | Not described Receives: Diagnostic Test: HPV genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of HPV subtypes in HIV-positive patients
Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment
Measured: 1 minute
Secondary outcomes (1)
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days
Measured: 30 minutes up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start1 Aug 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Sciensano
- Responsible party
- Principal investigator, prof. dr. Philip Roelandt, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Philip Roelandt, MD PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742375
- Sponsor's protocol ID
- S60050
- Acronym
- GAIN
- Status last verified
- Nov 2020
- First submitted
- 10 Oct 2018
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
- ClinicalTrials.gov ID
- NCT03742375
- Acronym / sponsor ID
- GAIN / S60050
- Conditions
- Human Immunodeficiency Virus
- Keywords
- Human Papilloma Virus, Anal Intraepithelial Neoplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Sciensano
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 15 Nov 2018 (actual)
- 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.
The pathophysiology from anal HPV infection to Anal Intraepithelial Neoplasia is less well understood than cervical HPV infection. In cervical screening programs it is well accepted that the sole presence of a high-risk HPV strain (irrespective of number of viral particles) is sufficient to justify further investigation and treatment. The investigators hypothesize that in anal HPV infection not only the presence but the extent of HPV infection (single genotype viral load) or combination of different HPV genotypes (cumulative viral load) is of importance in determining the risk of anal dysplasia.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HPV genotyping | Experimental | Diagnostic Test: HPV genotyping |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable HIV disease (i.e. receiving ART for at least 1 year, no adverse drug reactions requiring regular monitoring, no current illnesses or pregnancy, good understanding of lifelong adherence and evidence of treatment success: two consecutive undetectable viral load measures)
- Referred for high-resolution anoscopy
Key exclusion criteria (2 listed)
- Documented AIN (treated or untreated)
- Local anal inflammation (proctitis) and/or acute fissure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV genotypingQuantitative HPV genotyping on anal swab | Diagnostic test | HPV genotyping |
Primary outcome
Incidence of HPV subtypes in HIV-positive patients
Time frame: 1 minute
Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment
1 secondary outcome
Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
Time frame: 30 minutes up to 10 days
Results and safety
The study was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Philip Roelandt, MD PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV genotyping in people with Human Immunodeficiency Virus, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: COVID-19 pandemic). Results are not available in the source record.
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?
Incidence of HPV subtypes in HIV-positive patients (time frame: 1 minute). 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 4 Nov 2020.