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

NCT01946009 | Completed

• 1 other identifier: GESIDA-7412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

HIV

Outcome Measures

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

  8 Weeks

Secondary Outcomes (6)

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

  8 weeks

• Describe the percentage of patients that reduces the extent Intraepithelial Anal Dysplasia quadrants, although not complete regression

  8 Weeks

• Time to relapse

  8 Weeks

• Percentage of patients with clear of Human papillomavirus

  8 Weeks

• Percentage of adverse events

  8 weeks

Study Arms (1)

Cidofovir 1%

EXPERIMENTAL

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

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

Cidofovir 1%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. 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.
• \. Any disease or condition of the patient which, in the opinion of the investigator, is not adequate patient participation in the study.

Sponsors & Collaborators

• Fundacion SEIMC-GESIDA: lead

Study Sites (1)

Hospital Universitario La Paz

Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 26731755 DERIVED

MeSH Terms

Interventions

Cidofovir

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Cytosine; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elena Sendagorta, MD

  Hospital La Paz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: September 19, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 29, 2016

Record last verified: 2015-05

Locations

ES (1)