A Randomized, Double-blind, Double-simulated, Active-controlled，Phase III Clinical Study Evaluating the Efficacy and Safety of Azvudine Combined With Tenofovir Fumarate and Efavirenz in Hiv-infected Treatment Naive Patients
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 720
- 试验地点
- 12
- 主要终点
- Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
研究概览
简要总结
Azvudine,(FNC)， new nuclear nucleoside reverse transcriptase inhibitors, FNC make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance, approved by state drug administration (NMPA) for clinical research. FNC has completed its phase I、II clinical studies with desirable results.This is a multi-center, randomized, double-blind,double-placebo,active-control clinical trial. Subjects in experimental arm receives FNC+TDF+EFV+3TC placebo, while the subjected in active control arm receives 3TC+TDF+EFV+FNC placebo. The background drugs in both arms are conducted in open-label design while FNC and 3TC are conducted in double-blinded design.
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
- Double (Participant, Care Provider)
盲法说明
The experiment was conducted under a randomized method, each center disputed into the group via competition. Treatment assignment was carried out in accordance with a central randomization schedule generated with SAS (version 9.4). Randomization was done by a computer-generated system (IWRS). The randomization table (1st blind code) and second blind code were sealed and stored in triplicate offices of the sponsor, investigator and the independent statistician.
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
- •18-65 years old, regardless of gender;
- •Participant must have an positive HIV test;
- •Have not received anti-HIV treatment;
- •HIV-1 RNA≥1000 copies/ml and the investigators determined that the subjects were eligible for HAART therapy.
- •Who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration;
- •The subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent.
排除标准
- •History of allergy to any ingredient or excipient of the research drug or have a high sensitivity constitution;
- •Patients with severe opportunistic infection or tumor;
- •Clinically Hepatitis b surface antigen/hepatitis c antibody positive;
- •Clinically Alanine transaminase and/or alanine transaminase ≥5× normal upper limit (ULN);
- •Clinically Alanine aminotransferase ≥3×ULN and total bilirubin ≥2×ULN (direct bilirubin/total bilirubin > 35%);
- •Glomerular filtration rate < 70ml/min/1.73m2 (calculated by ckd-epi Creatinine 2009 Equation), or Creatinine ≥ULN;
- •Clinically significant diseases serious chronic diseases , metabolic diseases (such as diabetes), neurological and psychiatric diseases;
- •History of pancreatitis;
- •Women in pregnancy and breastfeeding;
- •History of drug abuse, alcohol abuse and drug abuse;
- •Participating in clinical trials of other drugs within the first three months of screening;
- •Other factors considered inappropriate by the investigator to be included in the study
研究组 & 干预措施
FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
干预措施: FNC (Drug)
FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
干预措施: TDF (Drug)
FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
干预措施: EFV (Drug)
FNC Treatment Group
FNC 3mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;3TC placebo 1 tablet;daily oral before bedtime
干预措施: 3TC placebo (Drug)
3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
干预措施: 3TC (Drug)
3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
干预措施: TDF (Drug)
3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
干预措施: EFV (Drug)
3TC control group
3TC 300mg, 1 tablet;TDF 300mg, 1 tablet;EFV 200mg, 2 tablets;FNC placebo 1 tablet;daily oral before bedtime
干预措施: FNC placebo (Drug)
结局指标
主要结局
Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 48
时间窗: 48 Weeks
Rate of participants with a HIV-1 RNA \< 50 copies per mL .If HIV RNA level is \< 50 copies per mL at Week 48, it is considered as virologic success as per the snapshot approach.
次要结局
- Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <400 copies/milliliter (c/mL) at Week 24 ，Week 48 and Week 96；(Week 24 and Week 48 and Week 96,)
- Diachronic change of CD4+T、 CD8+T cell count from baseline(Baseline and Week 96)
- Rate of subjects with plasma HIV-1 Ribonucleic acid (RNA) <50 copies/milliliter (c/mL) at Week 24 and Week 96(Week 24 and Week 96)
- Change of CD4+ cell count from baseline at Week 48 and Week 96(Week 48 and Week 96)
- Time to achieve virologic failure（HIV-1 RNA<50 copies/ml）(Baseline and Week 96)
- Safety outcome of subjects at Week 48 and Week 96。(Week 48 and Week 96)
- Diachronic change of logarithm (log) HIV-RNA reduction from baseline(Baseline and Week 96)