NCT00038506已完成4 期
A Phase IV, Open-label, Multicenter Study of Treatment With TRIZIVIR (Abacavir 300mg/Lamivudine 150mg/Zidovudine 300mg) Twice Daily and Tenofovir 300mg Once-daily for 48 Weeks in HIV-infected Subjects Experiencing Early Virologic Failure (ZIAGEN Intensification Protocol)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.
研究概览
简要总结
This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
- •Plasma HIV - 1 RNA was <400 copies/ml on at least 2 documented occasions prior to viral rebound.
- •Have a plasma HIV - 1 RNA value >400 copies/ml and <10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
- •A CD4+ lymphocyte count less than or equal to 100.
排除标准
- •Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
- •Have not had an AIDS defining illness within 30 days of screen.
- •Pregnant or breast-feeding.
- •Specified viral genotypes upon screening.
- •And other inclusion or exclusion criteria to be evaluated by the physician.
结局指标
主要结局
HIV viral load response at 48 weeks as measured by proportion of subjects with undetectable viral load.
时间窗: 48 weeks
次要结局
- Safety Viral load response at 24 weeks Change in T-cell count Resistance Health outcomes(24 weeks)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
4 期
Safety and Efficacy Study of Clevudine Compared With Clevudine and Vaccine in Patient With HBeAg(+) Chronic HBVHepatitis BNCT00501124Bukwang Pharmaceutical70
已完成
3 期
Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Teduglutide in Japanese Subjects With PN-dependent Short Bowel Syndrome (SBS)Short Bowel SyndromeNCT02340819Shire11
已完成
4 期
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)Chronic Rhinosinusitis With Nasal PolypsNCT05049122Sanofi25
已完成
4 期
Efficacy Evaluation for Inactivated Vaccine (Vero Cell) Against EV71Hand, Foot and Mouth DiseaseNCT03582761Jiangsu Province Centers for Disease Control and Prevention40,000
已完成
3 期
Acceptability of a Fixed Combination of Fenofibrate and MetforminDyslipidemia/Glucose Metabolism DisorderNCT00348725Solvay Pharmaceuticals69