A Phase II Randomized, Placebo-Controlled, Multi-Center Study to Evaluate the Safety, Tolerability, Immunogenicity, and Antiretroviral Activity of DermaVir Patch (LC002) in Treatment-Naïve HIV-1-Infected Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Percent of participants with primary safety endpoint
研究概览
简要总结
DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a single plasmid DNA expressing fifteen HIV antigens that assemble to HIV-like particles. These particles are safe; replication, integration and reverse transcription deficient. DermaVir is targeted to Langerhans cells by topical administration with DermaPrep. Langerhans cells with DermaVir migrate to lymph nodes and induce HIV-specific T cells that can kill HIV-infected cells.
GIEU006 is a Phase II randomized, placebo-controlled, dose-finding, double-blinded, multicenter study to assess the safety, tolerability, immunogenicity, and preliminary antiretroviral activity of DermaVir in antiretroviral therapy naïve adults with HIV-infection.
详细描述
Patients were randomized into one of the following 6 arms:
- Arm 1: Low dose DermaVir (0.2 mg DNA in 2 DermaPrep patches, n=9)
- Arm 2: Low dose Placebo (2 DermaPrep patches, n=3)
- Arm 3: Medium dose DermaVir (0.4 mg DNA in 4 DermaPrep patches, n=9)
- Arm 4: Medium dose Placebo (4 DermaPrep patches, n=3)
- Arm 5: High dose DermaVir (0.8 mg DNA in 8 DermaPrep patches, n=9)
- Arm 6: High dose Placebo (8 DermaPrep patches, n=3) DermaPrep Patch size: 80 cm2. DermaVir Standard Unit per patch is 0.1 mg DNA = 0.8 mL of DermaVir nanomedicine.
The patch sites for immunization are preferably the left or right upper back and left or right upper ventral thigh. The same skin sites should be used for all immunizations.
Immunization schedule (Days): 0, 42, 84, and 126.
The total DermaVir dose:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main inclusion Criteria:
- •HIV antibody positive
- •Plasma HIV RNA value ≥5,000 copies/mL and ≤ 150,000 c/mL
- •Antiretroviral therapy naïve
- •Documented CD4+ T-cell count at screening ≥400 cells/mm3
排除标准
- •No skin disease
- •No tattoos, or changes in pigmentation at the selected skin immunization sites
- •No acute or chronic illness (e.g Hepatitis C)
- •No chronic autoimmune diseases
- •No treatment with any immune modulating agents
研究组 & 干预措施
2: Low dose Placebo
- Dosage form: 1.6 mL Placebo
- Administration with 2 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 Placebo treatments)
干预措施: Placebo (Biological)
4: Medium dose Placebo
- Dosage form: 1.6 mL Placebo
- Administration with 4 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 Placebo treatments)
干预措施: Placebo (Biological)
6: High dose Placebo
- Dosage form: 6.4 mL Placebo
- Administration with 8 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 Placebo treatments)
干预措施: Placebo (Biological)
5: High dose DermaVir
- Dosage: 0.8 mg DNA
- Dosage form: 6.4 mL DNA/PEIm nanomedicine
- Administration with 8 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 DermaVir treatments)
干预措施: DermaVir (Biological)
3: Medium dose DermaVir
- Dosage: 0.4 mg DNA
- Dosage form: 3.2 mL DNA/PEIm nanomedicine
- Administration with 4 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 DermaVir treatments)
干预措施: DermaVir (Biological)
1: Low dose DermaVir
- Dosage: 0.2 mg DNA
- Dosage form: 1.6 mL DNA/PEIm nanomedicine
- Administration with 2 DermaPrep patches
- Frequency: every six weeks
- Duration: 18 weeks (4 DermaVir treatments)
干预措施: DermaVir (Biological)
结局指标
主要结局
Percent of participants with primary safety endpoint
时间窗: 24 weeks
Primary safety endpoint: occurrence of at least two \> Grade 3 adverse event including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment (as judged by the GIEU006 team, including site clinicians on the team, blinded to treatment arm) any time from the first day of study treatment until 42 days after the last study vaccine administration.
次要结局
- HIV-1 RNA(24 weeks)
- CD4+ and CD8+ T-cell counts(24 weeks)
- HIV-specific memory T cell responses(24 weeks)