N/A
N=276
Anal HPV Tests in Screening for Cell Changes in the Anus in Patients With HIV
Anal Cancer · HIV Infection · Human Papilloma Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT01946139 ↗Enrolled (actual)
276
Serious AEs
1.6%
Results posted
Sep 2022
Primary outcome: Primary: Specificity of Each Other Methods of HSIL Detection for APTIMA Assay — 116 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- comparison of screening methods (Procedure); laboratory biomarker analysis (Other); questionnaire administration (Other); quality-of-life assessment (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AIDS Malignancy Consortium
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Specificity of Each Other Methods of HSIL Detection for APTIMA Assay |
116 | — |
| PRIMARY Prevalence of HSIL |
69 | — |
| PRIMARY Sensitivity of Each of the Methods of APTIMA Assay at Baseline |
50 | — |
| PRIMARY Incidence of HSIL Among Women Who Were HRA Negative for HSIL at Study Entry |
9.08 | — |
| SECONDARY Acceptability of Anal Cancer Screening |
137 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01946139). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.