NCT02527096已完成2 期
A Pilot Trial Evaluating Maintenance Therapy With Lamivudine(Epivir®) and Dolutegravir(Tivicay®) in Human Immunodeficiency Virus 1 (HIV-1) Infected Patients Virologically Suppressed With Triple HAART - ANRS 167 Lamidol
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 18
- 主要终点
- Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)
研究概览
简要总结
The principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(Tivicay®) and lamivudine(TEpivir®) in HIV-1 infected patients virologically suppressed with triple HAART.
详细描述
Secondary objectives:
The following parameters will be evaluated :
- Evolution of CD4 cells and CD8 cells
- Tolerance to treatment
- Emergence of resistance mutations at time of virological failure
- HIV viral load measured with ultrasensitive assay (threshold 1 copy/mL) at Day 0, Week 8, Week 32 and Week 56
- Influence of total DNA at Day 0 on the occurrence of virological failure or blip
- Plasma levels of dolutegravir(Tivicay®) and lamivudine in participants with virological failure
- Adherence to treatment
- Quality of life
- Medico-economic aspects
- Dolutegravir(Tivicay®) and Nucleosidic Reverse Transcriptase Inhibitors (NRTIs) levels, and HIV viral load in semen in a subgroup of 20 participants.
Methodology:
Pilot trial, multicentric, national, prospective, no randomized and no comparative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •HIV-1 infected patient
- •Age ≥ 18 years
- •CD4 cell count nadir > 200/mm3
- •Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance group's algorithm which presents:
- •no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V, 154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the mutation A98S if the patient is not infected by the virus subtype C),
- •no mutation on integrase (if the genotype is available),
- •First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or 1 INI). The initial treatment may have changed a maximum of two times but only once for toxicity (changes such Epivir / Ziagen to Kivexa, are not considered as a change of treatment). However, treatment has to be unchanged in the last 6 months
- •Plasma HIV RNA ≤ 50 copies/mL for ≥ 2 years with at least 2 viral load determinations per year. Blips (HIV viral load between 50 and 200 copies/mL but ≤ 50 copies/mL on control sample) are allowed except in the last 6 months. The total number of blips must not exceed 3 in the last 2 years
- •Negative Hepatitis Bs Antigen
- •Effective contraception for women of childbearing potential
- •Informed consent form signed by patient and investigator
- •Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid ("Aide Médicale d'Etat" AME in France) is not a Social Security programme)
排除标准
- •HIV-2 infection
- •Positive HBc Ac isolated
- •Hepatitis B Virus (HBV) co-infected patients (positive Hepatitis Bs Ag at inclusion)
- •Chronic hepatitis C currently treated or needing therapy in the next 12 months
- •History of HIV-associated neurocognitive disorders
- •Current pregnancy or breastfeeding
- •No effective contraception for the women of childbearing
- •Previous treatment with chemotherapy (except bleomycin on Kaposi disease's treatment) or immunotherapy
- •Grade > 2 abnormality for usual biological parameters (liver function tests, blood cell count)
- •ALT(Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct bilirubinemia)
- •Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia, oesophageal or gastric varices or persistent jaundice)
- •Known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- •Creatininemia clearance below 50 mL/min (Cockroft-Gault method)
- •History or presence of allergy to the trial drugs or their components
- •Severe hepatic insufficiency (Child Pugh Class C)
- •Patients participating in another clinical trial including an exclusion period that is still in force during the screening phase
- •Patients under "sauvegarde de justice" (judicial protection due to temporarily and slightly diminished mental or physical faculties) or under legal guardianship.
研究组 & 干预措施
dolutegravir(Tivicay®) and lamivudine(Epivir®)
Experimental
干预措施: dolutegravir (Tivicay®) - Phase 1 (Drug)
dolutegravir(Tivicay®) and lamivudine(Epivir®)
Experimental
干预措施: lamivudine (Epivir®) - Phase 2 (Drug)
dolutegravir(Tivicay®) and lamivudine(Epivir®)
Experimental
干预措施: dolutegravir (Tivicay®) - Phase 2 (Drug)
结局指标
主要结局
Virological success without any intercurrent event leading to interrupt the strategy of the trial (analysis)
时间窗: from week 8 to week 56 (± 4 weeks)
Virological failure is defined by plasma HIV RNA \> 50 cp/mL on 2 following samples at 2 to 4 weeks apart.
次要结局
- Measure of quality of life (self-reported)(Day 0, week 8 and week 56)
- Percentage of participants with plasma HIV RNA < 1 cp/mL(Day 0, week 8, week 32 and week 56)
- Sperm substudy measure of concentration(Week 8 and week 32)
- Evolution of CD4 and CD8 lymphocytes count (analysis)(from week 8 to week 32 and week 56)
- Profile of resistance mutations in plasma in case of virological failure(week 56)
- Influence of total DNA on the occurrence of virological failure or blip(from Day 0 to week 56)
- Measure of adherence to treatment (self-reported)(Day 0, week 4, week 8, week 32 and week 56)
- Percentage of participants who discontinued the strategy of the trial for toxicity or with adverse event of grade 3 or 4 (analysis)(week 56)
- Measure of concentrations of dolutegravir(Tivicay®) and lamivudine(Epivir®) in case of virological failure or with a blip(week 56)
- Comparison of Medico-economic substudy (analysis)(week 56)
研究者
研究点 (18)
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