HIVCIDAN12NCT01946009
A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients
A study testing Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. in people with HIV, run by Fundacion SEIMC-GESIDA at 1 site in Spain.
Trial summary
Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2013to Sep 2014
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
- Adult patients (18 years) with documented HIV infection, with high-grade AIN demonstrated by biopsy, and have not received any prior treatment for Anal Intraepithelial Neoplasia in the last 12 weeks.
- For women of childbearing potential, negative pregnancy test in urine screening visit. All women of childbearing age should continue effective contraception throughout the study treatment.
Who cannot join
- 1. Patients who have received previous treatment of Anal Intraepithelial Neoplasia (AIN) in the last 12 weeks. 2. Dermatoses in patients with anogenital area 3. Patients with a history of pre-invasive neoplasia associated with Human Papilloma Virus 4. Patients with a history of previous neoplasm, of any origin and location, in the past 5 years.
- 5. Patients with a history of hematologic abnormalities, kidney or liver 6. Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator.
- 7. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).
- Conditions
- HIV
- Being tested
- Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.Drug
| Study group | Role | What they receive |
|---|---|---|
| Cidofovir 1% | Experimental | Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. Receives: Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with complete regression of anal intraepithelial neoplasia
Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN), as confirmed by means of high-resolution anoscopy and biopsy
Measured: 8 Weeks
Secondary outcomes (6)
Describe the percentage of patients that reduce the degree of Anal dysplasia
Describe the percentage of patients that reduce the degree of Anal dysplasia
Measured: 8 weeks
Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression
Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression
Measured: 8 Weeks
Time to relapse
Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse
Measured: 8 Weeks
Percentage of patients with clear of Human papillomavirus
Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir
Measured: 8 Weeks
Percentage of adverse events
Describe the number of patients with adverse events as a measure of safety and tolerability
Measured: 8 weeks
Treatment effect
Prospective Clinical Trial exploratory nature of the effect of treatment.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014
- Study completionSep 2014
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 HIVStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Sendagorta, MD, Principal investigator, Hospital La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946009
- Sponsor's protocol ID
- GESIDA-7412
- Acronym
- CIDAN12
- Status last verified
- May 2015
- First submitted
- 21 Mar 2013
- Last updated
- 29 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Sendagorta E, Bernardino JI, Alvarez-Gallego M, Feito M, Feltes R, Beato MJ, Perez-Molina JA, Yllescas M, Diaz-Almiron M, Arribas JR, Gonzalez-Garcia J, Herranz P; CIDAN127412 GESIDA Study Group. Topical cidofovir to treat high-grade anal intraepithelial neoplasia in HIV-infected patients: a pilot clinical trial. AIDS. 2016 Jan 2;30(1):75-82. doi: 10.1097/QAD.0000000000000886.
PubMed 26731755
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, With One Site, Open-label Not Controled Trial, for the Observation of Treatment With CIDOFOVIR 1%, 3 Nights Per Week, During 4 Weeks, of Anal Intraepithelial Neoplasia, High Level, in HIV+ Patients
- ClinicalTrials.gov ID
- NCT01946009
- Acronym / sponsor ID
- CIDAN12 / GESIDA-7412
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 19 Sep 2013 (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.
Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cidofovir 1% | Experimental | Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (3 listed)
- 1. Patients who have received previous treatment of Anal Intraepithelial Neoplasia (AIN) in the last 12 weeks. 2. Dermatoses in patients with anogenital area 3. Patients with a history of pre-invasive neoplasia associated with Human Papilloma Virus 4. Patients with a history of previous neoplasm, of any origin and location, in the past 5 years.
- 5. Patients with a history of hematologic abnormalities, kidney or liver 6. Pregnant or breastfeeding women or women of childbearing age who do not wish to use adequate contraception at the discretion of the investigator.
- 7. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.
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 |
|---|---|---|
| Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. | Drug | Cidofovir 1% |
Primary outcome
Percentage of patients with complete regression of anal intraepithelial neoplasia
Time frame: 8 Weeks
Describe the percentage of patients achieving complete regression of anal intraepithelial neoplasia (AIN), as confirmed by means of high-resolution anoscopy and biopsy
6 secondary outcomes
Describe the percentage of patients that reduce the degree of Anal dysplasia
Time frame: 8 weeks
Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression
Time frame: 8 Weeks
Time to relapse
Time frame: 8 Weeks
Percentage of patients with clear of Human papillomavirus
Time frame: 8 Weeks
Percentage of adverse events
Time frame: 8 weeks
Treatment effect
Time frame: 8 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 29 Jun 2016.
- Derived from this study: PubMed 26731755Sendagorta E, Bernardino JI, Alvarez-Gallego M, Feito M, Feltes R, Beato MJ, Perez-Molina JA, Yllescas M, Diaz-Almiron M, Arribas JR, Gonzalez-Garcia J, Herranz P; CIDAN127412 GESIDA Study Group. Topical cidofovir to treat high-grade anal intraepithelial neoplasia in HIV-infected patients: a pilot clinical trial. AIDS. 2016 Jan 2;30(1):75-82. doi: 10.1097/QAD.0000000000000886.
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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.
Elena Sendagorta, MD principal investigator
Hospital La Paz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. in people with HIV, run by Fundacion SEIMC-GESIDA 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 3 inclusion and 3 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 29 Jun 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 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.
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?
Percentage of patients with complete regression of anal intraepithelial neoplasia (time frame: 8 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 NCT01946009, 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 29 Jun 2016.