Clinical trial · Interventional
Quantitative HPV Genotyping in Screening of Anal Intraepithelial Neoplasia in HIV-positive Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): COVID-19 pandemic
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV genotyping | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HPV genotyping
- interventionNames
- Diagnostic Test: HPV genotyping
Primary outcomes (1)
- measure
- Incidence of HPV subtypes in HIV-positive patients
- timeFrame
- 1 minute
- description
- Retrieval of 1 anal swab before performing HRA to determine the HPV subtypes at that particular moment
Secondary outcomes (1)
- measure
- Correlation between high-resolution anoscopy findings and quantitative HPV genotyping
- timeFrame
- 30 minutes up to 10 days
- description
- Performing HRA (30 minutes) with or without biopsies, results biopsies up to 10 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria * 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 Exclusion criteria * Documented AIN (treated or untreated) * Local anal inflammation (proctitis) and/or acute fissure
References
Publications (0)
Data not yet available