A Phase II, Randomized, Double-blind, Multicenter, Immunogenicity Study of Vacc-4x Versus Placebo in Patients Infected With HIV-1 Who Have Maintained an Adequate Response to ART
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 18
- 主要终点
- Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
研究概览
简要总结
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore, ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
详细描述
Current management of HIV infection includes anti-retroviral therapy (ART). ART cannot cure the infection, making it a life-long treatment that requires sustained patient compliance and imposes significant individual and societal financial burdens on healthcare services. Furthermore,ART side effects often require medication that increases the inconveniences and financial burdens of HIV management. Of further concern is the emergence of viruses resistant to ART that can result in treatment failure.
ART-free periods could provide substantial benefit. Vacc-4x is a peptide-based HIV immunotherapy that is proposed for prolongation of ART-free periods. The purpose of this study is to determine whether Vacc-4x immunotherapy can give safe ART-free period.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55
- •HIV positive at least one year
- •Clinically stable on ART for at least six months
- •Documented viral load less than 50 copies/mL for the last six months
- •Documented prestudy CD4 cell count equal or more than 400x10exp6/L
- •Nadir CD4 cell count equal or more than 200x10exp6/L
- •Signed informed consent
排除标准
- •Reported pre-study AIDS-defining illness within the previous year
- •Malignant disease
- •On chronic treatment with immuno-suppressive therapy
- •Unacceptable values of hematology and clinical chemistry parameters
- •Current chronic infection such as HCV and HBV or active tuberculosis
- •Pregnant or breastfeeding women
- •Not using safe contraceptive methods
- •Participation in other clinical trial
- •Incapability of compliance
研究组 & 干预措施
Vacc-4x
Vacc-4x reconstituted in sterile water (0.1 mL) at a dose of 1.2mg per intradermal administration. Participants are given a total of 6 immunizations over 18 weeks (weeks 1, 2, 3, 4, 16, 18). Recombinant human granulocyte macrophage colony stimulating factor (rhuGM-CSF) Leukine (0.06mg in 0.1 mL) administered intradermally is used as a local adjuvant.
干预措施: Vacc-4x (Drug)
Placebo
Placebo injections consisting of sterile water (0.1 mL) in place of Vacc-4x. Placebo injections consisting of sterile water (0.1 mL) in place of Leukine.
干预措施: Sterile water (Drug)
结局指标
主要结局
Proportion of Subjects Who Require Resumption of ART Between the Interruption of ART at Week 28 and End of Study at Week 52.
时间窗: From Week 28 to Week 52
次要结局
- Effect of Vacc-4x on CD8 Counts(Weeks 6,18,24,28,32,36,40,44,48,52.)
- Time to Restart of ART for Vacc-4x Subjects Versus Placebo(Between Week 28 to Week 52)
- Effects on Vacc-4x on HIV-1 RNA(Weeks 24,28,32,36,40,44,48,52.)
- Number of Participants With Any Treatment Emergent Adverse Event, Related Treatment Emergent Adverse Events and Deaths(Up to week 52)
- Immunogenicity(Week 1, week 18 and week 52)