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

24 augustus 2026 bijgewerkt door: Daré Bioscience, Inc.

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

118

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85032
        • Werving
        • Precision Clinical Trials-Arizona
        • Hoofdonderzoeker:
          • Valerie Sorkin-Wells, MD
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72205
        • Werving
        • Applied Research Center of Arkansas/Cornerstone Clinic for Women
        • Contact:
    • Utah
      • Layton, Utah, Verenigde Staten, 84041
        • Werving
        • Alpine Research Organization, Inc.
        • Contact:
        • Hoofdonderzoeker:
          • Justin Mansfield, MD
    • Washington
      • Seattle, Washington, Verenigde Staten, 98104
        • Werving
        • Seattle Clinical Research Center
        • Hoofdonderzoeker:
          • Rebecca Dunsmoor-Su, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Provision of written informed consent prior to any study-specific procedures.
  2. Premenopausal women aged 22-50 years inclusive at the time of screening visit.
  3. 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.
  4. Generally, in good health with no clinically significant disease as determined by the Investigator.
  5. 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).
  6. 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.
  7. 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.

  8. 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.
  9. Ability and willingness to attend the necessary visits to the study center.
  10. Ability to comprehend all study related documentation, including written informed consent form, and complete all study-related tasks including daily diary.
  11. Be willing and able to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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]).
  5. 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.
  6. Positive result for hepatitis B, hepatitis C antibody or human immunodeficiency virus.
  7. 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.
  8. 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.
  9. Recent history (within 3 months prior to screening) of Stevens-Johnson syndrome, erythema multiforme, urticaria, or angioedema.
  10. Receipt of any investigational product within 30 days or 5 half-lives prior to dosing.
  11. 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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: DARE-HPV-LD 14 day
14 day administration of DARE-HPV low dose
Geneesmiddel: Lopinavir / ritonavir
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
Actieve vergelijker: DARE-HPV-LD 21 day
21 day administration of DARE-HPV low dose
Geneesmiddel: Lopinavir / ritonavir
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
Actieve vergelijker: DARE-HPV-HD 14 day
14 day administration of DARE-HPV high dose
Geneesmiddel: Lopinavir / ritonavir
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
Actieve vergelijker: DARE-HPV-HD 21 day
21 day administration of DARE-HPV high dose
Geneesmiddel: Lopinavir / ritonavir
A fixed-dose ration combination (12:1) of lopinavir and ritonavir in a vaginal capsule.
Geen tussenkomst: Placebo 14 day
14 day administration of placebo product
Geen tussenkomst: Placebo 21 day
21 day administration of placebo product

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy Endpoint
Tijdsspanne: 90 days
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 3 months post end of treatment
90 days

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Efficacy Endpoint
Tijdsspanne: 60 days
Proportion of participants with a negative high-risk human papillomavirus (hrHPV) qualitative test at 2 months post end of treatment
60 days

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Daré Bioscience, Inc.

Medewerkers

Advanced Research Projects Agency for Health (ARPA-H)

Onderzoekers

  • Studie directeur: Andrea Thurman, MD, Daré Bioscience, Inc.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

17 juli 2026

Primaire voltooiing (Geschat)

1 oktober 2027

Studie voltooiing (Geschat)

1 december 2027

Studieregistratiedata

Eerst ingediend

15 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 mei 2026

Eerst geplaatst (Werkelijk)

22 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • DARE-HPV-001
  • ARPA-H-ICHUB-24-101-248 (Ander subsidie-/financieringsnummer: ARPA-H)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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