A Randomised, Open Label, Prospective Study to Assess Two Different Therapeutic Strategies Following First Treatment Failure in HIV-1 Infected Subjects
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Mean change from baseline in peripheral and central adipose tissue
研究概览
简要总结
The purpose of this study is to look at two different antiretroviral treatment options in individuals who are about to commence their second antiretroviral treatment.
This study will assess important clinical and laboratory differences between these two therapeutic options. Potential differences include: differences in body fat distribution, in lipid parameters, in adherence and in neurocognitive (brain) function. This study is looking to show differences in body fat distribution between the two study treatment arms. Differences in lipids, viral load, adherence, cardiac and bone biomarkers and neurocognitive function will also be assessed. There is also a lumbar puncture sub study participants can also take part in.
The total duration of involvement in the trial will be up to 96 weeks (approximately 2 years) plus a screening visit 1 - 4 weeks prior to the start of the study. Including visit the clinic on 12 occasions (screening visit, baseline visit, weeks 2, 4, 8, 12, 24, 36, 48, 64, 80 and 96)
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
- •HIV-1 infected males or females
- •over 18 years of age
- •signed informed consent
- •currently receiving a stable antiretroviral regimen comprising of:
- •two or more licensed NRTIs
- •one licensed NNRTI or boosted protease inhibitor
- •no previous protease inhibitor resistance documented on HIV-1 genotypic resistance testing
- •failure of current antiretroviral regimen due to:
- •toxicity, intolerance or virological failure if receiving an NNRTI containing regimen at screening
- •toxicity or intolerance if receiving a boosted-protease inhibitor regimen at screening (with plasma HIV RNA < 400 copies/mL at screening)
- •willing to modify antiretroviral therapy, in accordance with the randomisation assignment
- •no previous exposure to etravirine
- •subjects in good health upon medical history, physical exam, and laboratory testing in the opinion of the investigator
- •have no serologic evidence of active HBV infection evidenced by negative hepatitis B surface antigen
- •female subjects who are heterosexually active and of childbearing potential (i.e., not surgically sterile or at least two years post menopausal) must practice contraception as follows from screening through completion of the study:
- •barrier contraceptives (condom, diaphragm with spermicide)
- •IUD or Depo PLUS a barrier contraceptive
- •female subjects of childbearing potential must have a negative pregnancy test.
排除标准
- •current alcohol abuse or drug dependence
- •pregnancy
- •active opportunistic infection or significant co-morbidities
- •current prohibited concomitant medication
- •a likelihood of diminished response to any of the study treatment arms, in the opinion of the investigator, based on HIV genotypic resistance testing
研究组 & 干预措施
Standard of care
干预措施: Darunavir, Ritonavir, Truvada (Drug)
NRTI sparing arm
干预措施: Darunavir, Ritonavir and Etravirine (Drug)
结局指标
主要结局
Mean change from baseline in peripheral and central adipose tissue
时间窗: week 48 and 96
As measured by DEXA, between treatment arms.
次要结局
- Percentage of patients <50 copies HIV-1 RNA/mL(96 weeks)
- Mean change from baseline Lipodystrophy Case Definition score(96 weeks)
- Describe aspects of immune reconstitution disease (IRD)(96 weeks)
- Comparison of quality of life and results of adherence questionnaires(96 weeks)
- Time to change in randomly assigned therapy(96 weeks)
- • Comparison of total number of patients with any serious adverse events (SAEs), and the cumulative incidence of SAEs(96 week s)
- Mean change from baseline of absolute CD4+ T cell count(96 weeks)
- Mean change from baseline in fasting lipid and glycaemia parameters(96 weeks)
- Patterns of genotypic HIV resistance associated with virological treatment failure(96 weeks)
- Mean change from baseline in cardiac and bone biomarker levels(Week 96)