Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)

Condition(s) studied

Investigational drug(s) / intervention(s)

Oral Immunomodulator: Oral immunomodulator administered twice daily for 3 months.

Vaginal Ovule: Vaginal ovule administered for 14 consecutive days each month for 3 months.

Standard Supportive Care: Standard supportive care according to routine clinical practice during the 3-month study period.

Study summary

Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.

Eligibility

Primary outcome measure(s)

• HPV clearance rate — 3 months
  The proportion of participants with a negative high-risk HPV test at the end of the 3-month treatment period.

Trial sites (1)

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