TCTR20210409003招募中3 期
Randomized-controlled trial evaluating the outcome between switching to tenofovir disoproxil fumarate(TDF)/lamivudine(3TC)/dolutegravir(DTG) versus maintaining the current NNRTI or boosted-PI -containing regimen in non-virologic failure HIV infection in Thailand
Atlanta Medicare0 个研究点目标入组 64 人开始时间: 2021年4月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Thai adult age > 18 year-old
- •2. Positive HIV-1 antibody or plasma HIV-1 viral load
- •3. Currently treated with 2NRTI/1NNRTI or boosted-PIs
- •4. Willing to participate throughout 48 weeks period and have a regular follow-up at Suddhavej hospital
排除标准
- •1. Women with childbearing age who wish to be pregnant in the next 52 weeks period
- •2. Women with childbearing age who deny contraception
- •3. Pregnant women
- •4. Documented HIV resistance
- •5. History of DTG hypersensitivity or the following substances: D-Mannitol, Microcystalline Cellulose, Povidone, Croscarmellose Sodium, Sodium Stearyl Fumarate, Talc, white film coat
- •6. Virologic failure
- •7. Creatinine clearance (CKD-EPI Asia) < 60 ml/min
- •8. Cirrhosis child B-C
- •9. Alanine aminotransferase (ALT) >= 5X of upper limit or ALT >= 3X +total bilirubin >= 1.5X of upper limit
- •10. Currently treated tuberculosis
- •11. Currently on >= 1000 mg of metformin
研究者
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