Human Papilloma Virus (HPV)Phase 2NCT07601074
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
A Phase 2 study testing Lopinavir / ritonavir in people with Human Papilloma Virus (HPV) and High-risk Human Papillomavirus Infection, run by Daré Bioscience, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 50 years, women only
- Conditions the study is for
- Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
- What is being tested?
- Lopinavir / ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Jul 2026to Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Regular menstrual cycle with an approximate 28-day cycle OR women who are amenorrheic due to effective contraception (such as levonorgestrel intrauterine system, or continuous oral contraception).
- Agree to refrain from vaginal douching, insertion of intravaginal devices (e.g., tampons, menstrual cups), and use of condoms for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.
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- Agree to abstain from all vaginal and oral intercourse for at least 48 hours before the first dose of study drug through at least 72 hours after the last dose of study drug.
- Women at risk of pregnancy must use a highly effective form of birth control (confirmed by the Investigator) for the entire duration of the study. Rhythm methods and consistent use of condoms will not be considered as highly effective methods of birth control. Highly effective forms of birth control include:
- Heterosexual abstinence
- Vasectomized male partner (provided that the male partner is the sole sexual partner of the female participant with childbearing potential and that the vasectomized partner has received medical assessment of the surgical success);
- Oral or transdermal combined ethinyl estradiol/progestin hormonal contraception associated with inhibition of ovulation;
- Oral, injectable or implantable progestogen-only hormone contraception associated with inhibition of ovulation (e.g., Depo-Provera™, Nexplanon, Slynd);
- Any effective copper intrauterine device/levonorgestrel intrauterine system;
- Female sterilization by tubal occlusion or bilateral salpingectomy;
- Supracervical hysterectomy.
- Ability and willingness to attend the necessary visits to the study center.
- Ability to comprehend all study related documentation, including written informed consent form, and complete all study-related tasks including daily diary.
- Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
Who cannot join
- 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]).
- Active pelvic infection (positive for gonorrhea or chlamydial infection, positive test and symptoms for bacterial vaginosis, candida vaginitis or trichomonal vaginitis). Participants with positive results can be treated and re-tested once during screening.
- Positive result for hepatitis B, hepatitis C antibody or human immunodeficiency virus.
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- Currently taking systemic immunosuppressants, biologics, intra-vaginal preparations, or any prescription that in the opinion of the Investigator could be a potential safety issue or interfere with the interpretation of the results.
- Previous exposure to lopinavir/ritonavir (within 3 months prior to screening), contraindication to the use of lopinavir/ritonavir or known allergy, hypersensitivity, or intolerance to any component of lopinavir/ritonavir excipients.
- Recent history (within 3 months prior to screening) of Stevens-Johnson syndrome, erythema multiforme, urticaria, or angioedema.
- Receipt of any investigational product within 30 days or 5 half-lives prior to dosing.
- Participants who, in the opinion of the Investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular, the study restrictions and risks involved).
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Not yet recruiting
AMR Clinical Columbus
Columbus, Ohio, 43213
Kayla Winters, 614-683-5800, kayla.winters@amr-clinical.com
Harold Green, MD
- Recruiting
Alpine Research Organization, Inc.
Layton, Utah, 84041
Chelsie Harding, 801-559-0410, charding@alpine-research.com
Justin Mansfield, MD
- Recruiting
Applied Research Center of Arkansas/Cornerstone Clinic for Women
Little Rock, Arkansas, 72205
Allie Barker, 501-954-7822, allie@arcarkansas.com
- Recruiting
Activian Clinical Research
Pearland, Texas, 77584
Lori Hoskins, Clinical Trials Associate Director, 713-795-5964, lhoskins@activian.com
Yvette Poindexter, MD
- Recruiting
Precision Clinical Trials-Arizona
Phoenix, Arizona, 85032
Ali Hamieh, 602-931-4507 ext. 100, ali@precisiontrials.com
Valerie Sorkin-Wells, MD
- Recruiting
Planned Parenthood North Central States
Saint Paul, Minnesota, 55408
Christy Boraas, MD, 651-696-5514, cboraas@ppncs.org
Christy Boraas, MD
- Recruiting
Seattle Clinical Research Center
Seattle, Washington, 98104
Recruitment Department, 206 522 3330 ext. 2, recruitment@seattlecrc.com
Rebecca Dunsmoor-Su, MD
- Recruiting
Del Sol Research Management LLC
Tucson, Arizona, 85715
Wendy Hotz, President, 520-526-0055, whotz@delsolresearch.com
Paige Brainard, MD
About this study
Official title: A Phase 2a, Multi-Center, Placebo-Controlled, Double-Blinded, Randomized, Dose Ranging Study of the Preliminary Efficacy of DARE-HPV to Treat Persistent High-Risk Human Papillomavirus (HPV) Genital Infection
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.
- Being tested
- Lopinavir / ritonavir
- Keywords
- HPV, hrHPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir / ritonavirDrug
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
| Study group | Role | What they receive |
|---|---|---|
| DARE-HPV-LD 14 day | Active comparator | 14 day administration of DARE-HPV low dose Receives: Drug: Lopinavir / ritonavir |
| DARE-HPV-LD 21 day | Active comparator | 21 day administration of DARE-HPV low dose Receives: Drug: Lopinavir / ritonavir |
| DARE-HPV-HD 14 day | Active comparator | 14 day administration of DARE-HPV high dose Receives: Drug: Lopinavir / ritonavir |
| DARE-HPV-HD 21 day | Active comparator | 21 day administration of DARE-HPV high dose Receives: Drug: Lopinavir / ritonavir |
| Placebo 14 day | No intervention | 14 day administration of placebo product |
| Placebo 21 day | No intervention | 21 day administration of placebo product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy Endpoint
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment
Measured: 90 days
Secondary outcomes (1)
Efficacy Endpoint
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 2 months post end of treatment
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start17 Jul 2026
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus (HPV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daré Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Research Projects Agency for Health (ARPA-H)
- Responsible party
- Sponsor
- Investigators
- Andrea Thurman, MD, Study director, Daré Bioscience, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601074
- Sponsor's protocol ID
- DARE-HPV-001
- Other IDs
- ARPA-H-ICHUB-24-101-248
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided