Pilot study of Anal Neoplasia Treatment in people with HIV Evaluation and monitoring (short title: PANTHER)

Not Applicable

Recruiting

Conditions: Anal High Grade Squamous Intraepithelial Lesions (HSIL)
People living with HIV
Human Papillomavirus
Surgery - Surgical techniques
Public Health - Other public health
Infection - Acquired immune deficiency syndrome (AIDS / HIV)

Registration Number: ACTRN12624000154505

Lead Sponsor: niversity of New South Wales Sydney, NSW, Australia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Aged 18 years or older
2.Documented HIV positive
3.Current patient of the Dysplasia and Anal Cancer Services (DACS) clinic under active follow-up
4. Histologically established persistent intra-anal HSIL of 4 or fewer octants diagnosed on 2 or more occasions, OR intra-anal HSIL considered by study doctor to be eligible for treatment
5.Willing to not undergo any other anal HSIL therapeutic interventions while taking part in the study. Treatment for anal conditions other than HSIL (such as dermatological abnormalities) may be allowed with the permission of the study doctor.
6. Able to provide written informed consent
7.No planned absences during the first 6 months of follow-up.

Exclusion Criteria

1.History of any other HSIL treatment within 3 months prior to the Baseline visit
2.Any perianal HSIL diagnosed, alone or in conjunction with intra-anal HSIL
3.Substantial quantity of anal verge HSIL subject to clinicians’ discretion
4. Intra-anal exophytic low-grade lesions, the extent of which compromises the ability to deliver effective electrocautery
5. Any anal or rectal pathology such as ulcer, fistula, stricture, or stenosis that, in the clinician’s assessment, is likely to adversely affect the efficacy of treatment
6.Concurrent malignancy requiring systemic therapy
7. At the clinician’s discretion, whether the participant is on a platelet inhibiting agent (e.g., Clopidogrel) and/or anti-thrombotic agent (e.g., Heparin or Rivaroxaban) and unable to discontinue 7 days before and after treatment for 14 days total.
oException: Aspirin 100 mg PO daily does not need to be discontinued
8.Undergoing Warfarin therapy
9.Pregnant or planning to become pregnant during the treatment period
10.Unwilling to comply with study-related procedures
11.Unable to undergo or tolerate the HRA procedure.
12. Has a pacemaker.