NCT02247687终止3 期
Management of Participants With Low-level Persistent Viremia (ANRS 161 L-VIR)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 20
- 主要终点
- Proportion of patients in Virologic success by week 12
研究概览
简要总结
Management of participants with low-level persistent viremia
详细描述
ANRS 161 L-Vir is a phase III prospective, randomized, multicenter, open-label, superiority trial for participants with low-level persistent viremia.
Participants will be randomized with a 1:1:1 ratio to the following three arms,
- Reference arm : counseling without antiretroviral treatment modification
- Switch arm : switch of current PI/r for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
- Addition of Isentress® (raltégravir) arm : Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
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
- 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
- •Age ≥ 18 years
- •HIV-1 infection
- •On combined antiretroviral regimen for at least 18 months
- •Participant with a stable antiretroviral regimen for at least 6 months, including 2 Reverse-transcriptase inhibitor (INTI) + 1 Boosted Protease Inhibitor IP/r ,
- •participant with at least 2 consecutive viral load between 50 and 500 copies/milliliter over the last 9 months (with at least 2 months between the two measurements) quantified with the same commercial kit.
- •50 <or= VL < 500 copies/milliliter at screening visit quantified with the same commercial kit than previous one.
- •Participant naïve to raltegravir (RAL)
- •failure of amplification or successful realization of genotypic resistance test without evidence for resistance mutations against current treatment (3TC/FTC accepted with M184V mutation)
- •creatinin < 3 Upper Limit normal (ULN)
- •Aspartate Amino Transférase (ASAT), Alanine Amino Transférase (ALAT) < 5 Upper Limit normal (ULN)
- •hemoglobin > 8 g/dL
- •platelets > 50 000/mm3
- •In women, lack of current pregnancy verified by Beta Human Chorionic Gonadotropin (βHCG) at week -4 visit and use of a mechanical contraceptive method
- •Informed consent
- •Participants with an active health insurance coverage (article L1121-11 du Code de la Santé Publique)
排除标准
- •HIV-2 infection,
- •severe medical condition in the last month (inclusion is possible for a stable condition at screening)
- •breastfeeding women, current pregnancy or planned pregnancy within 12 months.
- •participant currently receiving Prezista® (darunavir)/ Norvir® (ritonavir) (600/100 mg) two times a day (BID) (of note, participants receiving Prezista® (darunavir)/ Norvir® (ritonavir) one time a day (QD) can be included)
- •Hypersensitivity Prezista® (darunavir)/ Norvir® (ritonavir) or to any of the excipients of the study treatment
- •participant under judicial protection (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship
- •planned absence that could prevent the patient from participating in the trial (travel abroad, moving, pending work transfer ...)
研究组 & 干预措施
Counseling arm
Other
Counseling without antiretroviral treatment modification
干预措施: Counseling arm (Other)
Switch arm for protease inhibitor
Active Comparator
Switch arm for protease inhibitor : intervention is the switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling.
干预措施: Protease inhibitor (Drug)
Addition of Isentress® (raltegravir)
Active Comparator
Drug: Addition of Isentress® (raltegravir) arm
• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
干预措施: Isentress® (raltegravir) (Drug)
结局指标
主要结局
Proportion of patients in Virologic success by week 12
时间窗: week 12
A virologic success is defined by a patient having plasma HIV-1 RNA levels \<50 copies/ml at weeks 8 and 12.
次要结局
- Proportion of participants with HIV-1 RNA < 50 copies/ml(week 4, week 8, week 12, week 24, week 36, week 48)
- Proportion of participants with HIV-1 RNA <1copy/ml(week 8, week 12, week 24, week 36, week 48)
- Proportion of participants with HIV-1 RNA < 20 copies/ml(week 4, week 8, week 12, week 24, week 36, week 48)
- Levels of antiretroviral drugs in plasma(day 0 and end visit)
- Levels of antiretroviral drugs in hair(day 0, week 12, week 24and end visit)
- Levels of HIV-1 RNA in seminal plasma(day 0, week 12, week 48 and end visit)
- Change in CD4 cells count from baseline(week 12, week 24, week 48 and end visit)
- Quantification of HIV DNA in peripheral blood mononucleated cell (PBMC)(day 0)
- Number of Participants With Virologic Failure and Emergence of Resistance(day 0 and visit at failure time)
- Self-reported adherence(day 0, week 4, week 8, week 12, week 24, week 36, week 48 and end visit)
- Incidence of Study interruption(From day 0 to week 24)
- Incidence of clinical and biological adverse events(from day 0 to week 48)
研究者
研究点 (20)
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