A Randomized, Non-comparative, Phase IIb, Unblinded Trial, Evaluating the Efficacy and Safety of Tenofovir-emtricitabine or Lamivudine Plus Zidovudine, Lopinavir/Ritonavir, or Raltegravir, Among ARV-naïve HIV-2 Infected Adult Patients, in West Africa
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 9
- 主要终点
- The "overall success"
研究概览
简要总结
FIT-2 is a multi-country, phase IIb, randomized, non-comparative study, carried out in West Africa (Côte d'Ivoire, Burkina Faso, Senegal, Togo).
ARV-naïve HIV-2 infected adult patients will be recruited and followed during 96 weeks.
The objective is to evaluate the efficacy and safety of 3 first-line treatments in HIV-2 infected adult patients, in West Africa. A treatment will be considered as effective if more than 55% of patients in that arm attain "global success" at 96 weeks.
详细描述
Main objective
To determine in treatment-naïve HIV-2 infected patients, with CD4 counts above 200 cells/mm3, which of the following three regimens of first line treatment, Tenofovir (TDF), Emtricitabine or lamivudine (FTC or 3TC) plus Zidovudine (ZDV); TDF-FTC (3TC) plus Lopinavir/ritonavir (LPV / r); or TDF-FTC (3TC) plus raltegravir (RAL), will result in an "global success" rate of > 55% at week 96.
Number of participants : 210
Main outcome :
The proportion of patients with "global success" at W96, defined by survival with a plasma HIV-2 RNA viral load of <50 copies/ml and the non-occurrence of AIDS classified events (excluding tuberculosis) and the non-occurrence of severe morbidities non-AIDS-defining illness (cardiovascular disease, kidney disease, severe bacterial disease) and a delta of CD4 depending on the initial CD4 count (CD4 delta > +100cells/mm3 for initial CD4s between 201 and 500 cells/mm3 or delta ≥0 cells/mm3 for initial CD4s > +500 cells/mm3)
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
- •Infection by HIV-2 only;
- •Age > ou = 18 years;
- •Naïve for antiretroviral therapy (including antiretroviral treatment in the context of PMTCT except taking a dose of Nevirapine for PMTCT)
- •CD4 >200 cells/mm3
- •Resident of the city where the study is held or of city suburbs to facilitate participation
- •Signed informed consent document
排除标准
- •Current participation in any other clinical trial
- •Presence of opportunistic non-stabilized infections, of any serious or progressive disease, or of any clinical signs consistent with severe disease whose diagnosis is not yet confirmed, such as fever, weight loss, diarrhea or cough not yet explained (non-exhaustive list).
- •All pathology that leads in daily life to prefer one or the other of the three therapeutic regimens for medical reasons or to change the dosages specified in the test. This includes (but not limited to):
- •Hemoglobin ≤ 8 g / dL
- •Neutrophil count <500 cells/mm3
- •Renal impairment with creatinine clearance <50mL/mn
- •Blood platelet <50 000 cells/mm3
- •Decompensated heart failure
- •Hepatic failure Severe (TP<50% or cytolysis severe (ALAT> 3x ULN)
- •Active TB during treatment with rifampicin
- •Taking drugs that interact with the drugs of the clinical trial (as specified in the SPC)
- •Pregnancy, breastfeeding or planning to become pregnant during study follow-up
研究组 & 干预措施
Arm A : TDF + FTC (or 3TC) + ZDV
Tenofovir + Emtricitabine or Lamivudine + Zidovudine
干预措施: Tenofovir + Emtricitabine or Lamivudine + Zidovudine (Drug)
TDF+FTC (or 3TC) +LPV/r
Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir
干预措施: Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir (Drug)
Arm C : TDF +FTC (or 3TC) + RAL
Tenofovir + Emtricitabine or Lamivudine + Raltegravir
干预措施: Tenofovir + Emtricitabine or Lamivudine + Raltegravir (Drug)
结局指标
主要结局
The "overall success"
时间窗: 96 weeks
The proportion of patients with "global success" at W96, defined by survival with a plasma HIV-2 RNA viral load of \<50 copies/ml and the non-occurrence of AIDS classified events (excluding tuberculosis) and the non-occurrence of severe morbidities non-AIDS-defining illness (cardiovascular disease, kidney disease, severe bacterial disease) and a delta of CD4 depending on the initial CD4 count (CD4 delta\> +100cells/mm3 for initial CD4s between 201 and 500 cells/mm3 or delta ≥0 cells/mm3 for initial CD4s \> +500 cells/mm3) A treatment is considered to be effective if the "global success" is \> 55 % at 96 weeks.
次要结局
- Therapeutic failure(48 weeks)
- Incidence and type of severe clinical or biological severe adverse events per arm(between Week 0 and Week 96)
- The clinical progression(between Week 0 and Week 96)
- The evolution of CD4 counts(between Week 0 and Week 96)
- The evolution of plasma HIV-2 RNA load(between at W0 and W96)
- The observance of antiretroviral treatment(between W0 and W96)
- The resistance mutations profile(Weeks 96)
- The evolution of the HIV-2 DNA titers in PBMC(between Week 0 and Week 96)
- The frequency of treatment switches and discontinuations(between Week 0 and Week 96)
- To model the long-term survival and cost-effectiveness ratio(Weeks 96)