High-grade Anal Intraepithelial Neoplasia Clinical Trial
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05334004 -
Lopinavir/Ritonavir in PLWH With High-Grade AIN
|
Phase 1 |