High-grade Anal Intraepithelial NeoplasiaPhase 3TreatAINNCT04055142
Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
A Phase 3 study testing electrocoagulation, cidofovir 1% topical ointment and sinecatechins 10% topical ointment in people with High-grade Anal Intraepithelial Neoplasia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- High-grade Anal Intraepithelial Neoplasia
- What is being tested?
- electrocoagulation, cidofovir 1% topical ointment and sinecatechins 10% topical ointment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSpain
- Study dates
- 18 Sep 2020to 2 Jul 2024
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men who have sex with men, older or same than 18 years old.
- HIV-1 positive men.
- High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study.
- Informed consent is signed voluntarily.
Who cannot join
- Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.
- Treated patients for HGAIN in the previous 6 months.
- Patients with relapsed HGAIN two or more times in the last three months.
- People with learning difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).
The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.
All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.
Read the detailed description
This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost).
Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation.
On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.
- Being tested
- electrocoagulation, cidofovir 1% topical ointment, sinecatechins 10% topical ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrocoagulationProcedure or surgery
HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)
cidofovir 1% topical ointmentDrug
Also called Cidofovir
HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)
sinecatechins 10% topical ointmentDrug
Also called Veregen ointment
HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Electrocoagulation | Active comparator | This procedure will be implemented following the Standard of Care (SoC) on weeks: 0, 8 and 16 calculated since the day the patient is included into the trial. Receives: Procedure: electrocoagulation |
| Sinecatechins (10%) | Experimental | Topical ointment wich contains 2 grams of active principle (sinecatechins 10%) at each administration. It will be taken three times per week during 8 weeks of treatment. Receives: Drug: sinecatechins 10% topical ointment |
| cidofovir (1%) | Experimental | Topical ointment wich contains 2 grams of active principle (cidofovir 1%) at each administration. It will be taken three times per week during 8 weeks of treatment. Receives: Drug: cidofovir 1% topical ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia (HGAIN) with respect to electrocoagulation treatment in HIV-positive men who have sex with men.
Measured: 10 weeks
Secondary outcomes (6)
Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study.
By monitoring activities related with pharmacovigilance duties during the patient participation of each patient.
Measured: 48 weeks
Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study.
To describe the proportion of clinic and laboratory adverse events, which imply treatment dropout, in research treatment arm especially (cidofovir and sinecatechins). By monitoring activities related with pharmacovigilance duties during the patient participation of each patient
Measured: 48 weeks
Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
HIVTSQ has been modified by replacing the references to "HIV treatment" with "anal dysplasia treatment", and eliminating question 2 of HIVTSQ.
The following questions are related to the treatment you are being given in the trial and your experience in recent weeks. Please answer each question by circling a number on each of the scales evaluating them from 6 (very satisfied) to 0 (not satisfied).
- To what extent are you satisfied with your current treatment?
- To what extent are you satisfied with the side effects you have had from your current treatment?
- To what extent are you satisfied with the requirements related to your current treatment?
- To what extent do you consider your treatment to be comfortable / practical?
- o what extent do you think your treatment is flexible?
- To what extent are you satisfied with the information / knowledge you have about anal dysplasia?
- To what extent are you satisfied with the degree to which the treatment adapts to your
Measured: 48 weeks
% of patients who reduce the measurement in HGAIN octants, although without regression, by high-resolution anoscopy at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
To compare % of decreased extension of HGAIN patients, with absence of regression during the study period according to protocol schedule.
Measured: 10 weeks (+/- 4 weeks) after end of treatment
% of patients with no Human Papilloma Virus(HPV) detection at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
To compare % of Human Papilloma Virus clearance in patients during the study period according to protocol schedule.
Measured: 10 weeks (+/- 4 weeks) after end of treatment
Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment
During the study period according to protocol schedule.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start18 Sep 2020
- Primary completion11 Jan 2024
- Study completion2 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High-grade Anal Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase III, randomized, one-site, pilot, open-label, parallel groups trial for evaluating the efficacy and safety of electrocoagulation vs topic sinecatechins vs topic cidofovir within the treatment to high-grade anal intraepithelial neoplasia in HIV homosexual males.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055142
- Sponsor's protocol ID
- TreatAIN
- Acronym
- TreatAIN
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2019
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burgos J, Curran A, Garcia J, Campany D, Descalzo V, Suanzes P, Navarro J, Planas B, Sanchiz M, Landolfi S, Dinares C, Hernandez-Losa J, Falco V. Effectiveness of Electrocautery, Topical Cidofovir, and Topical Sinecatechins for the Treatment of Anal High-Grade Squamous Intraepithelial Lesions in Persons With HIV: An Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2025 Sep 16;81(2):333-340. doi: 10.1093/cid/ciaf086.
PubMed 40036375
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, One-site, Pilot, Open-label, Parallel Groups Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males
- ClinicalTrials.gov ID
- NCT04055142
- Acronym / sponsor ID
- TreatAIN / TreatAIN
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 18 Sep 2020 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 2 Jul 2024 (actual)
- First posted
- 13 Aug 2019 (actual)
- 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.
This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).
The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.
All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.
Detailed description
This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost).
Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation.
On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A phase III, randomized, one-site, pilot, open-label, parallel groups trial for evaluating the efficacy and safety of electrocoagulation vs topic sinecatechins vs topic cidofovir within the treatment to high-grade anal intraepithelial neoplasia in HIV homosexual males.
| Arm | Type | Receives |
|---|---|---|
| Electrocoagulation | Active comparator | Procedure: electrocoagulationThis procedure will be implemented following the Standard of Care (SoC) on weeks: 0, 8 and 16 calculated since the day the patient is included into the trial. |
| Sinecatechins (10%) | Experimental | Drug: sinecatechins 10% topical ointmentTopical ointment wich contains 2 grams of active principle (sinecatechins 10%) at each administration. It will be taken three times per week during 8 weeks of treatment. |
| cidofovir (1%) | Experimental | Drug: cidofovir 1% topical ointmentTopical ointment wich contains 2 grams of active principle (cidofovir 1%) at each administration. It will be taken three times per week during 8 weeks of treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men who have sex with men, older or same than 18 years old.
- HIV-1 positive men.
- High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study.
- Informed consent is signed voluntarily.
Key exclusion criteria (4 listed)
- Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.
- Treated patients for HGAIN in the previous 6 months.
- Patients with relapsed HGAIN two or more times in the last three months.
- People with learning difficulties
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 |
|---|---|---|
| electrocoagulationHIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks) | Procedure or surgery | Electrocoagulation |
| cidofovir 1% topical ointmentAlso: CidofovirHIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks) | Drug | cidofovir (1%) |
| sinecatechins 10% topical ointmentAlso: Veregen ointmentHIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks) | Drug | Sinecatechins (10%) |
Primary outcome
% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
Time frame: 10 weeks
% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks). sinecatechins 10% ointment treatment for high grade anal intraepithelial neoplasia (HGAIN) with respect to electrocoagulation treatment in HIV-positive men who have sex with men.
6 secondary outcomes
Number of Participants With Treatment-Related Adverse Events as assessed by CTCAE v4.0 during the study.
Time frame: 48 weeks
Number of Participants With analytical and clinical Adverse Events as assessed by CTCAE v4.0 during the study.
Time frame: 48 weeks
Median score obtained in the HIV Treatment Satisfaction Questionnaire (HIVTSQ).
Time frame: 48 weeks
% of patients who reduce the measurement in HGAIN octants, although without regression, by high-resolution anoscopy at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
Time frame: 10 weeks (+/- 4 weeks) after end of treatment
% of patients with no Human Papilloma Virus(HPV) detection at 10 weeks after end of treatment (with a permitted deviation of 4 weeks).
Time frame: 10 weeks (+/- 4 weeks) after end of treatment
Number of participants with a new HGAIN at histological sample after a complete or partial result after treatment
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 40036375Burgos J, Curran A, Garcia J, Campany D, Descalzo V, Suanzes P, Navarro J, Planas B, Sanchiz M, Landolfi S, Dinares C, Hernandez-Losa J, Falco V. Effectiveness of Electrocautery, Topical Cidofovir, and Topical Sinecatechins for the Treatment of Anal High-Grade Squamous Intraepithelial Lesions in Persons With HIV: An Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2025 Sep 16;81(2):333-340. doi: 10.1093/cid/ciaf086.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing electrocoagulation, cidofovir 1% topical ointment and sinecatechins 10% topical ointment in people with High-grade Anal Intraepithelial Neoplasia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 10 Jul 2024. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% of patients with complete or partial regression of high grade anal intraepithelial neoplasia (HGAIN) at 10 weeks after end of treatment (with a permitted deviation of 4 weeks). (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04055142, which also lists 1 linked publication.
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 10 Jul 2024.