NCT02232581已完成2 期
Randomised, Double Blind, Placebo-controlled Dose Ranging Trial to Determine the Antiviral Activity and Safety of Alovudine in Nucleoside-experienced HIV-infected Subjects Experiencing Virologic Failure
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 主要终点
- Mean change in HIV viral load measured from plasma samples
研究概览
简要总结
The primary objective was to determine the mean change in HIV viral load from baseline to Week 4 compared with placebo after 4 weeks of treatment in highly experienced HIV-infected patients.
Secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety of different doses of alovudine and (2) the effect of baseline nucleoside genotypic susceptibility on virologic response after 4 weeks of alovudine administration
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent before any trial procedure
- •HIV-1 infected males or females ≥18 years of age
- •Screening genotypic resistance report indicating two or more of the following nucleoside reverse transcriptase inhibitors (NRTI) resistance mutations: 41, 67, 70, 210 and 215
- •Stable NRTI regimen without stavudine and zidovudine for at least 6 weeks before screening and stable antiretroviral (ARV) background treatment for 3 months before screening
- •HIV-1 viral load ≥1000 copies/mL and <75,000 copies/mL at screening
- •Change in viral load between previous test within 3 months before screening, using local laboratory for routine tests, and screening test was <1.0 log10 copies/mL
- •Acceptable medical history, as assessed by the investigator
- •Current stable ARV medication regimen between screening (Visit 1) and Visit 2
排除标准
- •ARV medication naïve
- •Patients on recent drug holiday, defined as off ARV medications for at least 7 consecutive days within the previous 3 months
- •Female patients of child-bearing potential who :
- •have a positive serum pregnancy test
- •are breast feeding,
- •are planning to become pregnant, or
- •are not willing to use a barrier method of contraception
- •Prior alovudine use
- •Use of investigational medications within 30 days before study entry or during the trial
- •Use of immunomodulatory drugs within 3 months before study entry or during the trial (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2)
- •Current use of rifampin, rifabutine, isoniazid, pyrazinamide, stavudine, zidovudine, ganciclovir, chronic use of hepatotoxic drugs, anti-tumour therapy or probenecid
- •Laboratory values:
- •Neutrophils of Grade 2 or greater abnormality
- •Hemoglobin of Grade 2 or greater abnormality
- •Platelets: Grade 2 or greater abnormality
- •Creatinine of ≥1.25 Upper limit of the normal (ULN)
- •Lipase of Grade 1 or greater abnormality
- •Alanine aminotransaminase (ALT) or Aspartate aminotransaminase (AST) of Grade 2 or greater abnormality
- •Direct bilirubin of Grade 1 or greater abnormality
- •CD4 ≤50 cells/mm3
- •Hepatitis B (+HBsAg or +HBcAB) or C +Hepatitis C virus (+HCV AB ) co-infection, chronic hepatitis, on-going hepatitis or pancreatitis
- •Any new or active AIDS-defining event within 30 days before study entry
- •Inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator
- •In the opinion of the investigator, likely survival of less than 6 months because of underlying disease
研究组 & 干预措施
Alovudine - low
Experimental
干预措施: Placebo (Drug)
Alovudine - low
Experimental
干预措施: Alovudine - low (Drug)
Alovudine - medium
Experimental
干预措施: Alovudine - medium (Drug)
Alovudine - medium
Experimental
干预措施: Placebo (Drug)
Alovudine - high
Experimental
干预措施: Alovudine - high (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in HIV viral load measured from plasma samples
时间窗: Up to 4 weeks after drug administration
次要结局
- Mean change in CD4+ cell count(Up to 4 weeks after drug administration)
- Percentage of 0.5 virologic responders per treatment arm(Up to 4 weeks after drug administration)
- Percentage of load responders per treatment arm(Up to 4 weeks after drug administration)
- Percentage of 0.7 to 0.9 virologic responders per treatment arm(Up to 4 weeks after drug administration)
- Number of patients with adverse events(Up to 4 weeks after drug administration)
- Number of patients with laboratory test abnormalities and with respect to Division of AIDS (DAIDS) grading(Up to 4 weeks after drug administration)
- Number of patients with serious adverse events(Up to 4 weeks after drug administration)
- Percentage of virologic responders per treatment arm(Up to 4 weeks after drug administration)
- Proportion of patients experiencing a change of viral load(Up to 4 weeks after drug administration)
- Number of patients who discontinued due to adverse event(Up to 4 weeks after drug administration)
- Mean change in CD8+ cell count(Up to 4 weeks after drug administration)
- Number of patients with abnormal changes in laboratory parameters(Up to 4 weeks after drug administration)
研究者
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