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

NCT01663558 | Withdrawn Phase 4

• 1 other identifier: 23592103
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.To compare the efficacy of ablative therapy to topical imiquimod therapy in the management of anal dysplasia in HIV-infected men.
2. 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. 3.To describe demographic, sexual practices, HPV-specific, and HIV-specific correlates of anal dysplasia.
4. 4.To describe adverse effects associated with ablative therapy and topical imiquimod therapy.
5. 5.Anal Pap cytologic grade, including regression and recurrence during course of study
6. 6.HPV type in anal canal, including regression and recurrence during course of study
7. 7.Anal histology, including regression and recurrence during course of study
8. 8.Adverse effects experienced during treatment, recorded in symptom log

Conditions

Anal Dysplasia; Human Papilloma Virus; HIV

Keywords

anal dysplasia; HPV; HIV; MSM

Outcome Measures

Primary Outcomes (1)

• cytologic grade

  Anal Pap cytologic grade, including regression and recurrence during course of study

  3 months

Secondary Outcomes (1)

• HPV

  3 months

Other Outcomes (1)

• histologic grade

  3 months

Study Arms (3)

imiquimod

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.

Drug: imiquimod

ablative

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.

Procedure: ablative

Observation

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).

Interventions

imiquimod DRUG

Also known as: Aldara

imiquimod

ablative PROCEDURE

ablative

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead

Study Sites (1)

NMCSD

San Diego, California, 92134, United States

Location

MeSH Terms

Interventions

Imiquimod

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• John D Malone, MD

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: August 22, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)