Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
United States Naval Medical Center, San Diego
Information provided by (Responsible Party)
United States Naval Medical Center, San Diego
First received: August 9, 2012
Last updated: August 18, 2016
Last Verified: August 2016
History of Changes
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.
- 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.
- 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
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:
Human Papilloma Virus
Drug : imiquimod
Procedure : ablative
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV|
Further study details as provided by United States Naval Medical Center, San Diego:
Primary Outcome Measures
[ Time Frame: 3 months ]
Anal Pap cytologic grade, including regression and recurrence during course of study
[ Time Frame: 3 months ]
HPV type in anal canal, including regression and recurrence during course of study
- histologic grade [ Time Frame: 3 months ]
Anal histology, including regression and recurrence during course of study
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Other Name: Aldara
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.
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).
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Male gender, ≥18 years of age
- HIV-infected and taking ARVs with suppressed HIV VL (<48 copies/mL) on 2 consecutive measurements within the previous 6 months
- Any CD4 count will be considered appropriate for study
- Plasma INR < 1.5
- Plasma partial thromboplastin time (PTT) < 35s
- Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500
- Blood hemoglobin > 10.0 g/dL
- Blood platelet count > 50x103/mm3
- Serum total bilirubin < 6.0 mg/dL (subjects taking atazanavir-based ARV regimens may have elevated total bilirubin but are generally < 6)
- Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)
- Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)
- Serum creatinine < 1.5 mg/dL
- ECOG performance status < 3
- Tricare beneficiary
- History of AIN
- Anal canal condyloma requiring surgical treatment
- Anal cancer (current or history of)
- History of prior anal surgery, including hyfrecation, excision, cryotherapy, photocoagulation
- Use of anticoagulants (warfarin, heparin, Pradaxa)
- Inability to attend study visits
- Participation in any other drug study
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663558
Locations Show More
|United States, California|
|San Diego, California, United States, 92134|
Sponsors and CollaboratorsUnited States Naval Medical Center, San Diego
|Principal Investigator:||John D Malone, MD||United States Naval Medical Center, San Diego|
|Responsible Party:||United States Naval Medical Center, San Diego|
|ClinicalTrials.gov Identifier:||NCT01663558 History of Changes|
|Other Study ID Numbers:||23592103|
|Study First Received:||August 9, 2012|
|Last Updated:||August 18, 2016|
|Individual Participant Data|
|Plan to Share IPD:||No|
Keywords provided by United States Naval Medical Center, San Diego:anal dysplasia
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.