Clinical trial · Interventional
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Screening HIV-Infected Women for Anal Cancer Precursors
NCT01946139CI-TRIAL-00071078completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This clinical trial studies anal human papillomavirus (HPV) tests in screening for cell changes in the anus in patients with human immunodeficiency virus (HIV). Screening tests may help doctors find cancer cells early and plan better treatment for anal cancer. Completing multiple screening tests may help find the best method for detecting cell changes in the anus.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infection | — | UNRESOLVED | — |
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| comparison of screening methods | Procedure | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Screening (HSIL detection)
- description
- Patients undergo screening for the detection of HSIL using anal cytology, HPV hybrid capture 2, HPV mRNA assays, and OncoHealth HPVE6/E7 oncoprotein at baseline, at 6, 12, 18, and 24 months.
- interventionNames
- Procedure: comparison of screening methods
- Other: laboratory biomarker analysis
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (4)
- measure
- Specificity of Each Other Methods of HSIL Detection for APTIMA Assay
- timeFrame
- at baseline
- description
- Among patients who are HRA negative for HSIL, the number of participants who tested negative for HSIL on the APTIMA assay
- measure
- Prevalence of HSIL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HIV positive; HIV-1 infection, as documented by any federally approved, licensed HIV rapid test performed in conjunction with screening (or enzyme-linked immunosorbent assay \[ELISA\], test kit, and confirmed by Western blot or other approved test); alternatively, this documentation may include a record that another physician has documented that the participant has HIV infection based on prior ELISA and Western blot, or other approved diagnostic tests * Karnofsky performance status \> 70% * Absolute neutrophil count \>= 750 cells/mm\^3 within 120 days of study entry * Platelet count \>= 75,000 cells/mm\^3 within 120 days of study entry Exclusion Criteria: * Current or history of anal or perianal carcinoma * History of anal HSIL cytology or histology * Known permanent or irreversible bleeding disorder, or any illness that, in the opinion of the clinical investigator, would contraindicate any biopsy of the anal canal * For women able to conceive, evidence of pregnancy by a positive urinary pregnancy test; pregnant women are excluded from enrollment in this study * Serious medical or psychiatric illness that in the opinion of the site Investigator will interfere with the ability of the subject to give informed consent or adhere to the protocol * Ongoing use of anticoagulant therapy other than aspirin, clopidogrel or non-steroidal anti-inflammatory drugs (NSAIDS) * Inability to provide informed consent * Treatment of anal and/or perianal HPV associated disease (i.e., condyloma or low-grade anal intraepithelial neoplasia \[AIN\]) within 4 months of study entry
References
Publications (0)
Data not yet available
No reference posted for this study.