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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01663558
• Other study ID #: 23592103
• Status: Withdrawn
• Phase: Phase 4
• First received: August 9, 2012
• Last updated: August 18, 2016
• Start date: May 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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. 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Dysplasia
• HIV
• Human Papilloma Virus
• Hyperplasia
• Papilloma

Intervention

Drug:
• imiquimod

Procedure:
• ablative

Locations

Country	Name	City	State
United States	NMCSD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	histologic grade	Anal histology, including regression and recurrence during course of study	3 months	No
Primary	cytologic grade	Anal Pap cytologic grade, including regression and recurrence during course of study	3 months	No
Secondary	HPV	HPV type in anal canal, including regression and recurrence during course of study	3 months	No