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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by United States Naval Medical Center, San Diego
Sponsor:
Information provided by (Responsible Party):
Robert Carpenter, United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01663558
First received: August 9, 2012
Last updated: August 15, 2013
Last verified: August 2013

August 9, 2012
August 15, 2013
December 2013
December 2014   (final data collection date for primary outcome measure)
cytologic grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Anal Pap cytologic grade, including regression and recurrence during course of study
Same as current
Complete list of historical versions of study NCT01663558 on ClinicalTrials.gov Archive Site
HPV [ Time Frame: 3 months ] [ Designated as safety issue: No ]
HPV type in anal canal, including regression and recurrence during course of study
Same as current
histologic grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Anal histology, including regression and recurrence during course of study
Same as current
 
Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV

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:

  1. To compare the efficacy of ablative therapy to topical imiquimod therapy in the management of anal dysplasia in HIV-infected men.
  2. 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.
  3. To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of anal dysplasia.
  4. 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:

  1. Anal Pap cytologic grade, including regression and recurrence during course of study
  2. HPV type in anal canal, including regression and recurrence during course of study
  3. Anal histology, including regression and recurrence during course of study
  4. Adverse effects experienced during treatment, recorded in symptom log
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Anal Dysplasia
  • Human Papilloma Virus
  • HIV
  • Drug: imiquimod
    Other Name: Aldara
  • Procedure: ablative
  • Active Comparator: imiquimod

    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.

    Intervention: Drug: imiquimod
  • Active Comparator: ablative

    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.

    Intervention: Procedure: ablative
  • No Intervention: Observation

    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).

Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Male
18 Years and older
Yes
Contact: Patricia Schiffler 619-532-6251 patricia.schiffler@med.navy.mil
United States
 
NCT01663558
23592103
No
Robert Carpenter, United States Naval Medical Center, San Diego
United States Naval Medical Center, San Diego
Not Provided
Principal Investigator: Robert J. Carpenter, DO FACP NMCSD
United States Naval Medical Center, San Diego
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP