Introduction/Background Immunosuppressed human immunodeficiency virus (HIV) -positive patients are at greater risk of incident, persistent, or recurrent human papillomavirus (HPV) infection. They also have lower clearance rate, higher viral load, and a marked predisposition for being colonized by several serotypes; all leading to more frequent and severe HPV-dependent lesions. A Colorius versicolor-based vaginal gel have shown to repair HPV-dependent low-grade cervical lesions and to increase high-risk HPV clearance in immunocompetent HPV-positive patients. The aim is to provide evidence about the effectiveness of a multi-ingredient Coriolus versicolor-based vaginal gel on HPV-dependent cervical alterations and HPV clearance in HIV+ patients.

Methodology Pilot, prospective, one-cohort, observational study. 15 HIV-positive patients colonized by HPV in the endocervix region with an anomalous cervicovaginal cytology were included to receive a Coriolus versicolor-based vaginal gel 1 cannula/day for 21 days during first month + 1 cannula/alternate days for 5 months. Analysis of HPV patients with normal cytology and colposcopy image (improved alterations) and patients with HPV cleared (measured using hybrid capture test) is presented. The study was approved by an IRB and informed consent was signed by patients.

Results The overall HPV clearance and cytological normalization rates were 73.33% and 80%, respectively. Endocervical colonization by HPV also partially cleared in 13.33% of the cases. At the end of the study, the normalization of the colposcopy anomalies associated to HPV was achieved in 55.56%.

Conclusion Our results suggest that the proposed Coriolus versicolor-based vaginal gel treatment scheme could be an effective therapy in the management of endocervical HPV infection in HIV + patients. Its effects are similar to those obtained in patients without immunosuppression.