Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection

Completed · Phase 1 · Has a placebo group

Conditions studied: HSIL, HSIL of Cervix, High-Grade Squamous Intraepithelial Lesions, High-grade Cervical Intraepithelial Neoplasia, Human Papilloma Virus, Cervical Cancer, Cervical Intraepithelial Neoplasia, Cervical Neoplasm, Cervical Dysplasia, CIN

In brief

This study evaluates the use of topical ABI-1968 cream, in the treatment of cervical precancerous lesions in adult women.

Key facts

Study ID

NCT03239223

Run by

Antiva Biosciences

People needed

16

Starts

2018-01-01

Expected to finish

2018-10-30

Last updated by the study team

2019-07-10

Who can join

Age: 25 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women, 25 to 50 years old.
• Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
• Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
• Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).

You may not qualify if…

• Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
• History of cancer, except basal cell or squamous cell carcinoma of the skin.
• History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
• Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
• History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Where it is running

• Research Center — Los Angeles, California, United States
• Research Center — Lake Worth, Florida, United States
• Research Center — Idaho Falls, Idaho, United States
• Research Center — Chapel Hill, North Carolina, United States
• Research Center — Winston-Salem, North Carolina, United States
• Research Center — Norfolk, Virginia, United States
• Research Center — Camperdown, New South Wales, Australia
• Research Center — Darlinghurst, New South Wales, Australia
• Research Center — South Brisbane, Queensland, Australia

Full record on ClinicalTrials.gov

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