Suspended

Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV

What is being tested

imiquimod

+ ablative

DrugProcedure

Who is being recruted

Over 18 Years

+21 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 4

Interventional

Study Start: May 2015

See protocol details

Summary

Principal SponsorUnited States Naval Medical Center, San Diego

Last updated: August 22, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2015

Actual date on which the first participant was enrolled.

Context: Men who have sex with men (MSM) are at increased risk for HPV-related anal neoplasia and anal squamous cell carcinoma; concomitant HIV infection roughly doubles that risk. Objectives: To compare the efficacy of ablative therapy to topical imiquimod therapy in the management of anal dysplasia in HIV-infected men. To describe relationship between cytologic grade of anal dysplasia (as reported on screening anal Pap test) and pathologic grade reported on anal mucosa histopathologic examination. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of anal dysplasia. To describe adverse effects associated with ablative therapy and topical imiquimod therapy. Design: Prospective, randomized controlled clinical trial. This will be a pilot study. All subjects will undergo baseline anal Pap, HRA with biopsies as indicated, and anal HPV testing. If AIN 2 or 3 is discovered on histopathologic examination, subject will be offered observation only or treatment. If he chooses treatment, he will be randomized to: 1) imiquimod anal suppositories three times weekly for 3 months, or 2) appropriate ablative therapy as determined by colorectal surgeon. During imiquimod treatment (not applicable to ablative group as their treatment will be completed in one visit) subjects will be followed for 2 weeks, 4 weeks, 8 weeks, and 12 weeks with anal Pap, HRA with biopsies as indicated, and anal HPV testing. After therapy completed in each treatment group, subjects will be followed for 1 month, 3 months, 6 months, 9 months, and 12 months post-therapy with anal Pap, HRA with biopsies as indicated, and anal HPV testing. Observation only subjects will be evaluated every 3 months with anal Pap, HRA with biopsies as indicated, and anal HPV testing for 12 months. We have chosen a goal of 30 subjects in each treatment group and 10 subjects in the observation only group based on the likelihood of enrolling a study of this type in a reasonable amount of time. Main Outcome Measures: Anal Pap cytologic grade, including regression and recurrence during course of study HPV type in anal canal, including regression and recurrence during course of study Anal histology, including regression and recurrence during course of study Adverse effects experienced during treatment, recorded in symptom log

NCT01663558

Principal SponsorUnited States Naval Medical Center, San Diego

Last updated: August 22, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Male

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

14 inclusion criteria required to participate

Any CD4 count will be considered appropriate for study

Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500

Blood alanine aminotransferase (ALT) < 130 U/L ( < 2 ULN)

Blood aspartate aminotransferase (AST) < 100 U/L ( < 2 ULN)

Show More Criteria

7 exclusion criteria prevent from participating

Anal canal condyloma requiring surgical treatment

Anal cancer (current or history of)

History of AIN

History of prior anal surgery, including hyfrecation, excision, cryotherapy, photocoagulation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

i. Each subject will use an imiquimod anal suppository three times weekly (overnight on Monday, Wednesday, Friday) for 12 weeks. ii. Each subject will be asked to abstain from receptive anal sex during therapy period (12 weeks). iii. If local imiquimod adverse effects are severe, a 7-day period off of treatment will be permitted. iv. During 12 week therapy period, each subject will be evaluated 2, 4, 8, and 12 weeks after starting therapy. At each visit, subject will complete a therapy questionnaire and undergo anal Pap, HRA with biopsies as indicated, and anal HPV testing. v. After therapy completed (12 weeks), subject will enter 12 month observation period.

Group II

Active Comparator

i. Subject will be referred to colorectal surgeon, will complete a therapy questionnaire, and will be treated in accordance with treatment algorithm which is already in use. ii. Subject will be asked to abstain from receptive anal sex for 12 weeks after ablative therapy. iii. After therapy, subject will enter 12 month observation period.

Group III

No Intervention

i. Given lack of accepted guidelines and outcome data on dysplasia management, the study PI will thoroughly discuss risks and benefits of observation/monitoring and treatment of dysplasia. ii. If treatment is chosen, subject will be randomized to 1) ablative group, or 2) imiquimod group and begin therapy. Observation subjects will continue observation visits (observation questionnaire, anal Pap, HRA with biopsies as indicated, and anal HPV testing) every 3 months for 12 months (4 additional study visits).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

NMCSD

San Diego, United StatesOpen NMCSD in Google Maps

SuspendedOne Study Center