A Phase Ib Randomized, Double-blind, Placebo-controlled, Ascending Sequential Dose, Adaptive Design Study to Evaluate the Safety, Antiretroviral Activity, and Pharmacokinetics of Intravenous Deferiprone in Treatment-Naïve HIV-Positive Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- ApoPharma
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
This study will evaluate the safety, tolerability, antiretroviral activity, pharmacokinetics, and pharmacodynamics of an intravenous formulation of deferiprone in HIV-infected subjects.
详细描述
This is a double-blind, placebo-controlled, randomized trial in 30 asymptomatic HIV-positive adults. There are two sequential cohorts, in which subjects will receive either one of 2 doses of deferiprone or placebo twice daily.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-1 positive
- •HIV treatment-naïve: no previous treatment with a combination anti-retroviral therapy (cART) or highly active anti-retroviral therapy (HAART) regimen
- •HIV-1 RNA > 10,000 copies/mL
- •ALT or AST ≤ 2.0 x upper limit of normal range, and bilirubin within normal range
- •Body mass index (BMI) of 18.5 to 30.0 kg/m^2
- •Absolute neutrophil count at baseline of ≥1.0 x 10^9/L (black African population only) or ≥1.5 x 10^9/L (all other races)
排除标准
- •Evidence of AIDS-associated illness, excluding superficial candidiasis
- •CD4+ T-cell count of < 350/mm^3
- •Positive for active or latent tuberculosis, as determined by the QuantiFERON®-TB Gold test
- •Active, serious infections (other than HIV-1 infection) within the 30 days prior to screening
- •Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis virus C (HCV) antibodies
- •History or presence of malignancy
- •A serious, unstable chronic illness during the past 3 months before screening
- •A serious, unresolved acute illness at screening
研究组 & 干预措施
Intravenous deferiprone, 1.5 g
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 1.5 g, twice-daily
干预措施: Intravenous deferiprone (Drug)
Intravenous deferiprone, 2 g
Subjects in this arm will receive an infusion of intravenous deferiprone at a dose of 2 g, twice-daily
干预措施: Intravenous deferiprone (Drug)
Placebo
Subjects in this arm will receive an infusion of placebo twice-daily for 10 days, at a volume equivalent to that of the active product in the respective cohort
干预措施: Placebo (Drug)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Day 1 to Day 56
Change from baseline in level of HIV DNA in peripheral blood mononucleated cells
时间窗: Day 1 to Day 56
Proportion of subjects withdrawn due to the need for rescue medication
时间窗: Day 1 to Day 56
Change from baseline in HIV viral load
时间窗: Day 1 to Day 56
Change from baseline in CD4+ T-cell count
时间窗: Day 1 to Day 56
次要结局
- The pharmacokinetics parameters of Cmax, Tmax, and AUC0-∞, and T1/2 for deferiprone will be determined pre-dose and at specified time points post-dose(10-hour interval)