NCT00036634已完成1 期
A Phase 1/2, Randomized, Double-Blind, Active Controlled, Dose Escalation Study of the Safety, Tolerance, Pharmacokinetic,, and Antiviral Activity of GS-7340-02 in Antiretroviral-Naive Patients Who Are Chronically Infected With HIV-1
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
研究概览
简要总结
This study evaluated two doses of tenofovir alafenamide versus tenofovir disoproxil fumarate (tenofovir DF).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Tenofovir DF
Active Comparator
Participants received tenofovir DF 300 mg for 14 days
干预措施: Tenofovir DF (Drug)
Tenofovir alafenamide 50 mg
Experimental
Participants received tenofovir alafenamide 50 mg for 14 days
干预措施: Tenofovir alafenamide (Drug)
Tenofovir alafenamide 150 mg
Experimental
Participants received tenofovir alafenamide 150 mg for 14 days
干预措施: Tenofovir alafenamide (Drug)
结局指标
主要结局
Time-weighted average change from baseline through Week 2 (DAVG2) for HIV-1 RNA (log10 copies/mL)
时间窗: Baseline to Week 2
DAVG2 was defined as the time-weighted average between baseline value through the last available value up to week 2 minus the baseline value.
次要结局
- Change from baseline in HIV-1 RNA (log10 copies/mL)(Baseline to Week 2)
- Change from baseline in CD4 cell count (cells/mm3)(Baseline to Week 2)
研究者
研究点 (3)
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