CTRI/2017/11/010679已完成4 期
Multicenter, Open-Label, Randomized, Prospective Phase IV, Interventional, Non-Inferiority Study with Blinded Assessment, to Evaluate the Efficacy and Safety of Fixed Dose Combination (FDC) of Tenofovir/Lamivudine/Low Dose Efavirenz (300/300/400mg) Vs Tenofovir/Lamivudine/Low Dose Efavirenz (300/300/600mg) in Adult Indian Patients with HIV-1 Infection.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 265
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
入选标准
- •1. To provide written informed consent.
- •2. BMI >= 18 kg/m2.
- •3. Confirmed HIV-1 infection.
- •4. Plasma HIV-1 viral load of at least 1000 copies per mL.
- •5. For females of childbearing potential, a negative serum pregnancy.
排除标准
- •1. Pregnant or nursing female.
- •2. Previous AIDS defining illness.
- •3. Any uncontrolled opportunistic infection or malignancy.
- •4. Absolute neutrophil counts lower than 500 cells per μL.
- •5. Platelet count lower than 50,000 cells per μL.
- •6. Serum transaminases more than five-times the upper limit of normal.
- •7. Subjects with Hemoglobin >= 7 g/dL or 4.34 mmol/L.
- •8. Subjects with renal impairment (eGFR <50 mL/min/1.73 m2).
- •9. Subjects on medicinal products contraindicated to use Tenofovir, Lamivudine and Efavirenz.
- •10. Patient having history of clinically-significant illness or any other major medical disorder.
- •11. History of GI disorder that interferes with metabolism.
- •12. Patients with known hypersensitivity to the investigational product.
- •13. Subject is unable to follow study instructions or comply with procedures involved as per protocol.
- •14. Any other condition as per the physicianâ??s discretion that would make the subject ineligible for the study.
研究者
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