Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS, Hematology |
| Therapuetic Areas: | Hematology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/13/2015 |
| Start Date: | December 2013 |
| End Date: | December 2015 |
| Contact: | Patricia Schiffler |
| Email: | patricia.schiffler@med.navy.mil |
| Phone: | 619-532-6251 |
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
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
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
We found this trial at
1
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