NCT00528957已完成3 期
A Phase III, Randomized, Open-Label Study Comparing the Safety and Efficacy of Switching Stavudine or Zidovudine to Tenofovir Disoproxil Fumarate Versus Continuing Stavudine or Zidovudine in Virologically Suppressed HIV-Infected Children Taking Highly Active Antiretroviral Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 9
- 主要终点
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
研究概览
简要总结
The primary objective of this study is to assess the efficacy of switching to tenofovir disoproxil fumarate (TDF) compared to continuing stavudine or zidovudine in maintaining virologic suppression in HIV-1 infected children.
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
- None
入排标准
- 年龄范围
- 2 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented laboratory diagnosis of HIV-1 infection
- •Plasma HIV-1 RNA < 400 copies/mL
- •Currently on a stable stavudine or zidovudine -containing antiretroviral therapy regimen for at least 12 weeks
- •Naive to tenofovir DF
- •Key Inclusion Criteria for the First 96-Week Extension
- •Completed 48 weeks of treatment in Arm 1 or Arm 2 of the study
- •<18 years of age (at the start of the extension)
- •Participants initially randomized to Arm 2 will be given the option to replace stavudine or zidovudine with tenofovir DF in the 96-week extension at the investigator's discretion, if the investigator determines that tenofovir DF is safe and beneficial for the participant.
- •Key Inclusion Criteria for the Second and Third 96-Week Extension and Fourth Open-Ended Extension
- •Completed of treatment with study drug in the first extension phase
- •<18 years of age at the start of the extension. This inclusion criterion is not applicable in those regions where tenofovir DF is not commercially available for treatment of HIV-1 infection in adults.
排除标准
- •Participants receiving ongoing therapy with any of the following
- •Nephrotoxic agents
- •Systemic chemotherapeutic agents
- •Systemic corticosteroids
- •Interleukin 2 (IL 2) and other immunomodulating agents
- •Investigational agents
- •Pregnant or lactating participants
- •Evidence of a gastrointestinal malabsorption syndrome or chronic nausea or vomiting which may confer an inability to receive an orally administered medication
- •Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance
- •Malignancy other than cutaneous Kaposi's sarcoma (KS) or basal cell carcinoma.
- •Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic therapy within 15 days prior to screening
- •Prior history of significant renal disease (ie, nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis)
- •Prior history of significant bone disease (ie, osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)
- •Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
Tenofovir DF
Experimental
干预措施: Tenofovir DF (Drug)
stavudine or zidovudine
Active Comparator
干预措施: Zidovudine (Drug)
stavudine or zidovudine
Active Comparator
干预措施: Stavudine (Drug)
结局指标
主要结局
Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 48
时间窗: 48 weeks
This is the percentage of participants with HIV-1 RNA \< 400 copies/mL after 48 weeks of exposure to randomized study drug.
次要结局
- Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 400 Copies/mL, Snapshot)(48 weeks)
- Virologic Success at 48 Weeks (HIV-1 RNA Cutoff at 50 Copies/mL, Snapshot)(48 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 96(96 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at Week 144(144 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 192 Weeks(192 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 240 Weeks(240 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 288 Weeks(288 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 336 Weeks(336 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 384 Weeks(384 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 432 Weeks(432 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 480 Weeks(480 weeks)
- Percentage of Participants With HIV-1 RNA < 400 Copies/mL at 528 Weeks(528 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 48 Weeks(48 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 96 Weeks(96 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 144 Weeks(144 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 192 Weeks(192 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 240 Weeks(240 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 288 Weeks(288 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 336 Weeks(336 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 384 Weeks(384 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 432 Weeks(432 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 480 Weeks(480 weeks)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at 528 Weeks(528 weeks)
- Change From Baseline in CD4 Percentage at 48 Weeks(Baseline and 48 weeks)
- Change From Baseline in CD4 Percentage at 96 Weeks(Baseline and 96 weeks)
- Change From Baseline in CD4 Percentage at 144 Weeks(Baseline and 144 weeks)
- Change From Baseline in CD4 Percentage at 192 Weeks(Baseline and 192 weeks)
- Change From Baseline in CD4 Percentage at 240 Weeks(Baseline and 240 weeks)
- Change From Baseline in CD4 Percentage at 288 Weeks(Baseline and 288 weeks)
- Change From Baseline in CD4 Percentage at 336 Weeks(Baseline and 336 weeks)
- Change From Baseline in CD4 Percentage at 384 Weeks(Baseline and 384 weeks)
- Change From Baseline in CD4 Percentage at 432 Weeks(Baseline and 432 weeks)
- Change From Baseline in CD4 Percentage at 480 Weeks(Baseline and 480 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 240 Weeks(Baseline and 240 weeks)
- Change From Baseline in CD4 Percentage at 528 Weeks(Baseline and 528 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 48 Weeks(Baseline and 48 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 96 Weeks(Baseline and 96 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 144 Weeks(Baseline and 144 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 192 Weeks(Baseline and 192 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 288 Weeks(Baseline and 288 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 336 Weeks(Baseline and 336 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 384 Weeks(Baseline and 384 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 432 Weeks(Baseline and 432 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 480 Weeks(Baseline and 480 weeks)
- Change From Baseline in CD4 Cell Count (Cells/mm^3) at 528 Weeks(Baseline and 528 weeks)
研究者
研究点 (9)
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