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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-09-30

Brief Summary

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

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cidofovir 1%

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients who have given informed consent in writing of the study before making any specific selection procedure for the study.
2. 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.
3. 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No