Single Center, Placebo Controlled, Double-Blind Study to the Treatment of HPV Infected Cervix With AV2 Antiviral Spray and Assessment of Viral Load
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
研究概览
简要总结
This study aims to prove that, by a one-time topical spray on the cervix, AV2-DM is an effective antiviral in reducing on short term (3 months) the human papillomavirus (HPV) infection.
- Primary endpoint: significant drop in viral load AV2-DM versus placebo
- Secondary endpoint:the number of patients with adverse events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 25 and 40 years
- •Patient has been recently (up to 6 months) Quantitatively (Viral Load) and Qualitatively (HPV types) diagnosed with HPV.
- •Ability and willingness to participate in the study.
- •Subject agrees to refrain from using prescription or supplemental antiviral medications without obtaining permission of the Treating Doctor.
- •Voluntary written informed consent.
排除标准
- •Subject has been vaccinated against HPV
- •Interval between a delivery and T0 is less than 3 months
- •Subject has a gynecologic surgical intervention between T0 and T1
- •Subject is diagnosed HPV negative at T0
- •Subject has a (adeno)carcinoma in situ.
- •Females with child bearing potential who are not using a reliable, medically accepted method of birth control
- •Pregnant or breast-feeding female, or women planning to become pregnant during the trial.
- •Medical history of immunosuppression by radiotherapy, chemotherapy, immuno-modulatory drugs, or HIV.
- •Participation to another clinical trial concerning HPV infections within 6 months before the application of AV2-DM antiviral spray.
- •Medical history of any severe diseases like hepatitis, renal or liver dysfunction, car-diovascular, gastrointestinal, malignant tumor(s), or psychiatric disorders etc., which might influence the assessments or conduct of the trial by the discretion of the investigator.
- •Intake or application of antivirals or other prohibited concomitant medication within 30 days prior to application of AV2, or patients who plan to take such drugs during the trial.
- •Known or suspected allergic or adverse response to the investigational product AV2-DM Antiviral spray, it's components, olive oil or d-limonene.
- •Inability to follow the study protocol.
研究组 & 干预措施
olive oil with 10% d-limonene
Topical spray one-time administration 2 puffs of 100µl
干预措施: cervical swab with Cervex-Brush-Combi at T0 (Procedure)
olive oil with 10% d-limonene
Topical spray one-time administration 2 puffs of 100µl
干预措施: topical spray on the cervix (Drug)
olive oil with 10% d-limonene
Topical spray one-time administration 2 puffs of 100µl
干预措施: cervical swab with Cervex-Brush-Combi at T1 (Procedure)
AV2-DM antiviral spray
Topical spray one-time application 2 puffs of 100µl
干预措施: topical application cervical spray (Drug)
AV2-DM antiviral spray
Topical spray one-time application 2 puffs of 100µl
干预措施: cervical swab with Cervex-Brush-Combi at T0 (Procedure)
AV2-DM antiviral spray
Topical spray one-time application 2 puffs of 100µl
干预措施: cervical swab with Cervex-Brush-Combi at T1 (Procedure)
结局指标
主要结局
Efficacy comparison number of patients with drop (min 2 Log units) in HPV specific viral load AV2-DM versus placebo
时间窗: 90 days
次要结局
- number of adverse vents AV2-DM versus placebo(90 days)