DARE-HPV for Human Papillomavirus
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called DARE-HPV to determine its effectiveness in clearing persistent high-risk human papillomavirus (hrHPV) infections. Researchers aim to evaluate the effectiveness of different doses and treatment durations compared to a placebo. Women who have had a persistent hrHPV infection for at least 12 months and are generally in good health may qualify for this study. This trial offers a valuable opportunity for those seeking to manage their hrHPV infection effectively. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are taking systemic immunosuppressants, biologics, or intra-vaginal preparations, you may not be eligible to participate. It's best to discuss your current medications with the study team.
Is there any evidence suggesting that DARE-HPV is likely to be safe for humans?
Research has shown that DARE-HPV is being developed to specifically treat ongoing high-risk HPV infections. Although direct data on DARE-HPV is not yet available, treatments for HPV, such as vaccines, are generally considered very safe. Studies have found that HPV vaccines are usually well-tolerated, with mild side effects like soreness at the injection site.
DARE-HPV is currently in Phase 2 trials, indicating that early tests have demonstrated its safety for further study. This phase builds on initial safety data, suggesting that the treatment may already be generally well-tolerated. For more detailed information, discussing any concerns with the trial's research team is advisable.12345Why do researchers think this study treatment might be promising?
Researchers are excited about DARE-HPV because it offers a potentially new approach to treating Human Papillomavirus (HPV). Unlike typical treatments that often focus on managing symptoms or preventing the virus through vaccines, DARE-HPV is being studied as a therapeutic option that might directly target and reduce the viral load. The trial explores both low-dose and high-dose versions of the treatment over different durations, suggesting flexibility in its application and potentially greater effectiveness. This could be a game-changer for those already infected with HPV, providing a treatment that directly addresses the virus itself rather than just preventing infection or managing symptoms.
What evidence suggests that this trial's treatments could be effective for hrHPV?
Research shows that DARE-HPV is being developed as a promising treatment for ongoing high-risk human papillomavirus (hrHPV) infections. This new therapy directly targets the infection in the body. While researchers are still learning about DARE-HPV's effectiveness in people, it resembles other successful antiviral treatments. Previous studies with HPV vaccines have shown that targeting the virus can effectively reduce infections and related diseases, suggesting that DARE-HPV might work similarly. Although specific data remains limited, the treatment aims to clear hrHPV infections, offering hope for those dealing with persistent cases.24678
Who Is on the Research Team?
Andrea Thurman, MD
Principal Investigator
Daré Bioscience, Inc.
Are You a Good Fit for This Trial?
This trial is for premenopausal women aged 22-50 who have had a high-risk genital HPV infection (types 16, 18, or others) for at least a year. Participants must be in good health and agree to avoid vaginal products and sex around the time of treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive DARE-HPV or placebo for 14 or 21 days to treat persistent high-risk HPV
Follow-up
Participants are monitored for safety and effectiveness after treatment, with primary outcomes measured at 30, 60, or 90 days
What Are the Treatments Tested in This Trial?
Interventions
- DARE-HPV
Trial Overview
The study tests DARE-HPV (lopinavir/ritonavir) at two different doses and durations (14 or 21 days), compared to placebo, to see if it can clear persistent high-risk HPV infections. Participants are randomly assigned to groups.
How Is the Trial Designed?
6
Treatment groups
Active Control
14 day administration of DARE-HPV low dose
21 day administration of DARE-HPV low dose
14 day administration of DARE-HPV high dose
21 day administration of DARE-HPV high dose
14 day administration of placebo product
21 day administration of placebo product
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daré Bioscience, Inc.
Lead Sponsor
Advanced Research Projects Agency for Health (ARPA-H)
Collaborator
Citations
Innovation in HPV Treatment Research
DARE-HPV is an innovative localized antiviral therapy being developed to address persistent high-risk HPV infection and reduce the risk of cervical disease ...
Human Papillomavirus Vaccine Efficacy and Effectiveness ...
HPV vaccination has been shown to be highly effective against oral HPV type 16/18 infection, with a significant percentage of participants developing IgG ...
HPV Evidence Review
The review found strong and consistent evidence of vaccine effectiveness against cervical cancer, precancerous lesions, and persistent HPV infection. Meta- ...
HPV Vaccine Safety and Effectiveness Data
More than 15 years of monitoring and research have accumulated reassuring evidence that HPV vaccination provides safe, effective, and long-lasting protection.
A Study of the Preliminary Efficacy of DARE-HPV to Treat ...
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 ...
Human Papillomavirus (HPV) Vaccine Safety
A closer look at the safety data. HPV vaccines are safe. Findings from many vaccine safety monitoring systems and more than 160 studies have ...
Safety of HPV vaccines
No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe. Further safety data have been generated recently from ...
8.
cidrap.umn.edu
cidrap.umn.edu/human-papillomavirus-hpv/evidence-review-finds-hpv-vaccines-be-safe-extremely-effectiveEvidence review finds HPV vaccines to be safe, extremely ...
“The data show how important HPV vaccination is to prevent persistent HPV infections that lead to cancer,” said Angela Ulrich, PhD, MPH, ...
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