Anal DysplasiaPhase 4NCT01663558
Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
A Phase 4 study testing imiquimod and ablative in people with Anal Dysplasia and Human Papilloma Virus, run by United States Naval Medical Center, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anal Dysplasia, Human Papilloma Virus, HIV
- What is being tested?
- imiquimod and ablative
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Objectives:
- 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.
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:
- 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
- Adverse effects experienced during treatment, recorded in symptom log
- Conditions
- Anal Dysplasia, Human Papilloma Virus, HIV
- Being tested
- imiquimod, ablative
- Keywords
- anal dysplasia, HPV, HIV, MSM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imiquimodDrug
Also called Aldara
ablativeProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
cytologic grade
Anal Pap cytologic grade, including regression and recurrence during course of study
Measured: 3 months
Secondary outcomes (1)
HPV
HPV type in anal canal, including regression and recurrence during course of study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2012 (estimated)
- Study startMay 2015
- Primary completionDec 2015 (estimated)
- Study completionMay 2016 (estimated)
Why it stopped: funding not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John D Malone, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01663558
- Sponsor's protocol ID
- 23592103
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2012
- Last updated
- 22 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV
- ClinicalTrials.gov ID
- NCT01663558
- Acronym / sponsor ID
- 23592103
- Conditions
- Anal Dysplasia, Human Papilloma Virus, HIV
- Keywords
- anal dysplasia, HPV, HIV, MSM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- May 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 13 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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:
- 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
- Adverse effects experienced during treatment, recorded in symptom log
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| imiquimod | Active comparator | Drug: imiquimodi. 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. |
| ablative | Active comparator | Procedure: ablativei. 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. |
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imiquimodAlso: Aldara | Drug | imiquimod |
| ablative | Procedure or surgery | ablative |
Primary outcome
cytologic grade
Time frame: 3 months
Anal Pap cytologic grade, including regression and recurrence during course of study
1 secondary outcome
HPV
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D Malone, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing imiquimod and ablative in people with Anal Dysplasia and Human Papilloma Virus, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cytologic grade (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.