A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)

ConditionsHuman Papilloma Virus (HPV)High-risk Human Papillomavirus Infection

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexFemale

Age22-50

SponsorDaré Bioscience, Inc.

About this trial

The goal of this clinical study is to learn if DARE-HPV can treat persistent high-risk human papillomavirus (hrHPV). The primary outcome will be if the genital infection clears following treatment in 30, 60 or 90 days.

The study will look at two different doses of DARE-HPV and two different treatment durations of 14 and 21 days compared to a placebo group or 14 or 21 days of treatment.

Eligibility criteria

Qualifiers

Provision of written informed consent prior to any study-specific procedures.

Premenopausal women aged 22-50 years inclusive at the time of screening visit.

Positive result for genital hrHPV (types 16, 18, or 'other') on at least 2 tests over the span of at least 12 months (history of persistent hrHPV infection for at least 12 months), based on review of participant's medical records. The visit 1 screening genital hrHPV test may be the second positive test.

Generally, in good health with no clinically significant disease as determined by the Investigator.

Disqualifiers

Any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the results of the study, or the participant's ability to participate in the study.

Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during screening and at baseline, which in the opinion of the Investigator, may put the participant at risk because of her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.

Cytological abnormality of the uterine cervix defined as LSIL or mild cervical intraepithelial neoplasia (CIN1), or HSIL or moderate (CIN 2) or severe (CIN 3) histology, as proven by cytology or colposcopic biopsy collected within the 12 months prior to screening or cytology at screening.

Pregnant, breastfeeding, or lactating women (WOCBP must have a negative urine pregnancy test at screening and at the start of treatment [i.e., Day 1]).

Trial design

Treatments tested in this trial

Lopinavir / ritonavir

Treatment groups

118 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Sponsors and collaborators

Daré Bioscience, Inc.

Lead sponsor

Advanced Research Projects Agency for Health (ARPA-H)

Collaborator

Source ClinicalTrials.gov