NCT02067767已完成2 期
Phase 2 Multicentric Open-label Study of Switch From Abacavir/Lamivudine Fixed Dose Combination Plus Nevirapine to Abacavir/Lamivudine/Dolutegravir in Virologically Suppressed HIV-1 Infected Adults
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
- 53
- 试验地点
- 2
- 主要终点
- Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12
研究概览
简要总结
Abacavir/Lamivudine + Nevirapine (ABC/3TC + NVP) is a very effective and well tolerable regimen on the long-term. However this regimen comprises 2 pills per day. Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) offers simplification with a single pill per day with no food constraints, Dolutegravir (DTG) having the advantage over Nevirapine (NVP) of high potency, higher genetic barrier to resistance, with a very good safety profile. The objective of this study is to evaluate the virologic safety (maintenance of virologic suppression) after switching from ABC/3TC + NVP to ABC/3TC/DTG in 50 HIV-1 infected adults with prolonged HIV RNA suppression on ABC/3TC + NVP, as well as clinical and laboratory safety. Because nevirapine is a strong inducer of hepatic enzymes, pharmacocinetic (PK) assessment will be performed in all patients in the first weeks after switch and 24-hours PK in a subset of 10 patients after 5 days of DTG addition to current regimen, before switching to ABC/3TC/DTG.
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
- •Patient with confirmed HIV-1 infection (HIV antibody positive confirmation prior to screening)
- •Age ≥ 18 years
- •Written informed consent
- •Male patient or non-pregnant, non-lactating female patient
- •On antiretroviral treatment with nevirapine (400 mg per day) plus abacavir/lamivudine for more than 6 months; Nevirapine 400 mg/day being administered as either 1 x 200 mg IR x 2/day or 2 x 200 mg IR qd or 1 x 400 mg XR qd
- •No history of prior virologic failure on antiretroviral therapy
- •HIV-1 RNA < 50 copies/ml for more than 1 year,
- •No major IAS-USA nucleoside reverse transcriptase inhibitors or integrase inhibitors resistance mutations on genotypic testing on last plasma sample with HIV-1 RNA > 500 c/mL (if available)
- •HLA-B*5701 negative test
- •Subjects covered by Health Insurance
排除标准
- •Woman of child-bearing potential without effective contraception method. Pregnant or breastfeeding woman.
- •Woman expecting to conceive during the study period
- •HIV-2 co-infection
- •Any prior exposure to integrase inhibitor(s)
- •Plasma HIV-1 RNA > 50 c/mL in the past year
- •Creatinine clearance < 60 ml/mn (estimated glomerular filtration rate according to the MDRD equation),
- •Alkaline phosphatase, ASAT or ALAT ≥ 5 times the upper limit of the norm (ULN)
- •Patient with history of decompensated liver disease
- •Any major IAS-USA mutation conferring resistance to one or more of reverse transcriptase or integrase inhibitors on any historical plasma genotype if available. Any previous genotype result is valid, with no time limit, as long as the original test result is documented.
- •Mycobacteriosis under treatment
- •Malignancy requiring chemotherapy or radiotherapy
- •Positive HBs Ag
- •HCV infection for which specific treatment is ongoing or planned during the study
- •Known hypersensitivity to one of the trial drugs, the metabolites or formulation excipients
- •Concomitant therapy with antacids or H2 antagonists
- •Contraindicated concomitant treatment
- •Anticipated non-compliance with the protocol
- •Participation in another clinical trial with an on-going exclusion period at screening
- •Subject under legal guardianship or incapacitation
- •Subject, who in the opinion of the investigator, is unable to complete the study period
研究组 & 干预措施
Abacavir/Lamivudine/Dolutegravir
Experimental
Patients switched from their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG.
干预措施: Abacavir/Lamivudine/Dolutegravir (Drug)
结局指标
主要结局
Percentage of patients with plasma HIV-1 RNA < 50 copies/mL at week 12
时间窗: Week 12
次要结局
- Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W24(Week 24)
- Percentage of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W12(Week 12)
- Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W36(Week 36)
- Plasma concentration of dolutegravir between W0 and W12(Week 12)
- Evaluation of patient's satisfaction with HIVTSQs and HIVTSQc questionnaires(Week 48)
- Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W48(Week 48)
- CD4 and CD8 measurement(Week 48)
- Urinary albumine:creatinine ratio measurement(Week 48)
- Fasting lipids measurement(Week 48)
- Plasma concentration of NVP between Week 0 (W0) and Week 2 (W2)(Week 2)
- CD14 and usCRP measurement over 48 weeks(Week 48)
- Percentage of patients with Plasma HIV-1 RNA < 50 copies/ml at W48(Week 48)
- Number of patients with undetectable plasma viral load (< 1 copies/ml or signal not detected) at W24(Week 24)
- Percentage of patients with adverse event of any Grade over 12 weeks(Week 12)
- Percentage of patients with adverse event of Grade 3 or 4 over 48 weeks(Week 48)
- Serum creatinine and GFR (MDRD) measurement(Week 48)
- Plasma concentration of DTG on 24h at D0 and Week 2(Week 2)
研究者
研究点 (2)
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