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A Phase 2a Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV).

NCT07601074 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Lopinavir / ritonavir

A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.

Sponsors & Collaborators

  • Advanced Research Projects Agency for Health (ARPA-H)

    collaborator UNKNOWN

  • Daré Bioscience, Inc.

    lead INDUSTRY

Principal Investigators

  • Andrea Thurman, MD · Daré Bioscience, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-10-31
Completion
2027-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07601074 on ClinicalTrials.gov