Dolutegravir-Lamivudine as Dual Therapy in naïve HIV-Infected Patients With Documented M184V Mutation:A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- HIV viral load efficacy at week 48
研究概览
简要总结
The purpose of this study is to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV patients with a documented M184V mutation.
详细描述
This is a pilot study designed to evaluate the antiviral efficacy, safety and tolerability of dual therapy with 3TC and DTG as initial therapy among naïve HIV-1 subjects ≥ 18 years old carrying the M184V mutation
This will be evaluated as the proportion of patients with pVL < 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
This study will consist of a screening period of up to 42 days, a 48-week treatment period, followed by a 4-week post-treatment follow-up (FU) period to document late adverse events.
The study will include 20 HIV-1-infected subjects, meeting all inclusion criteria and not meeting any exclusion criteria for this study.
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
- 是
入选标准
- 未提供
排除标准
- •Patients will NOT be selected to be part of this study if they meet ANY of the following criteria:
- •Alcohol or drug use that might impact on adherence
- •Subjects positive for Hepatitis B at screening (+HBsAg), or anticipated need for Hepatitis C virus (HCV) therapy during the study
- •Women who are pregnant or breastfeeding, or women who plan to become pregnant in the next 2 years
- •interferon, interleukin-2, cytotoxic chemotherapy, Dofetilide (or pilsicainide) or immunosuppressors, antacid drugs containing Ca++ and or Mg++ at study entry
- •Grade 4 lab abnormalities
- •Primary HIV infection (indeterminate WB or previous negative HIV in the last 6 months
- •Opportunistic infection (CDC C category) or other disease and/or clinical condition that, in the investigator's opinion, would compromise the patient's safety or outcome of the study; including malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia
- •Subjects who in the investigator's judgment, poses a significant suicidality risk.
- •History or presence of allergy to the study drugs or their components or drugs of their class
- •Treatment with any of the following agents within 28 days of screening: radiation therapy; cytotoxic chemotherapeutic agents; any immunomodulators that alter immune responses or treatment with an HIV-1 immunotherapeutic vaccine within 90 days of screening or exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product
- •Any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound;
- •Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN), or ALT ≥ 3xULN and bilirubin ≥ 1.5xULN (with >35% direct bilirubin)
- •Creatinine clearance of <50mL/min via Cockroft-Gault method
- •Subjects with moderate to severe hepatic impairment (Class B or greater) as determined by Child-Pugh classification
研究组 & 干预措施
single arm
dolutegravir 50 mg QD plus lamivudine 300 mg QD
干预措施: Dolutegravir plus lamivudine (Drug)
结局指标
主要结局
HIV viral load efficacy at week 48
时间窗: 48 weeks
the proportion of patients with pVL \< 50 copies/mL at week 48 using the ITT-exposed analysis (FDA snaphot).
次要结局
- HIV viral resistance mutations(At week 48)
- HIV viral load efficacy at week 24(week 24 and week 36)
- immunological response in CD4 cell count(baseline and week 48)
- adverse events(baseline to 48 weeks)
- lipid profile change(baseline and week 48)
研究者
Pedro Cahn
Scientific director
Fundación Huésped