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CompletedNCT01946009CIDAN12Updated Jun 29, 2016

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

An interventional study of Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks. in HIV, sponsored by Fundacion SEIMC-GESIDA. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-29.

Sponsored by Fundacion SEIMC-GESIDA · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

Cidofovir could be an effective drug for the treatment of Anal Intraepithelial Neoplasia(AIN).

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Conditions studied

  • HIV

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

Fundacion SEIMC-GESIDA is the lead sponsor of 29 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.

    1. 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.
    2. 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.

Exclusion criteria

  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.

    1. 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.
    1. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Cidofovir 1%

    Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.

    Drug: Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.

Interventions

  • DrugCidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.
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What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 Weeks

Secondary outcomes

  1. Describe the percentage of patients that reduce the degree of Anal dysplasia

    Describe the percentage of patients that reduce the degree of Anal dysplasia

    Time frame: 8 weeks

  2. 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

    Time frame: 8 Weeks

  3. Time to relapse

    Describe the percentage of patients with recurrence after complete regression of HSIL and median time to relapse

    Time frame: 8 Weeks

  4. Percentage of patients with clear of Human papillomavirus

    Describe the percentage of patients in whom Human Papillomavirus clears after treatment with cidofovir

    Time frame: 8 Weeks

  5. Percentage of adverse events

    Describe the number of patients with adverse events as a measure of safety and tolerability

    Time frame: 8 weeks

  6. Treatment effect

    Prospective Clinical Trial exploratory nature of the effect of treatment.

    Time frame: 8 Weeks

07

Study locations

1 site
  • Hospital Universitario La Paz
    Madrid, Spain
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01946009
Lead sponsor
Fundacion SEIMC-GESIDA
Responsible party
Sponsor
First posted
Sep 19, 2013
Start date
Sep 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Jun 29, 2016

Study contacts

Elena Sendagorta, MD
principal investigator · Hospital La Paz

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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