An Open Label Trial of STRIBILD™ (Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate) for ARV-naïve HIV-2 Infected Adults in Dakar, Senegal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
There is a critical need for safe and effective antiretroviral treatment (ART) regimens for HIV-2 infection. This is especially true in West Africa, where the vast majority of the 1-2 million individuals infected with HIV-2 live and were access to effective ART for HIV-2 is limited. HIV-2 is intrinsically resistant to non-nucleoside reverse transcriptase inhibitors (NNRTI) and the fusion inhibitor enfuvirtide (T-20) and mutations conferring broad resistance to nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) are frequently observed in HIV-2 from patients receiving ART. Although antiretroviral protease inhibitors (PI) can be used effectively to treat HIV- 2, HIV-1 and HIV-2 also exhibit important differences in their susceptibilities with studies indicating that saquinavir (SQV), lopinavir (LPV), and darunavir (DRV) are the only potent PI's against HIV-2 replication and cross-resistance is frequent. Although an increasing body of evidence supports the potential utility of integrase inhibitors (INI) against HIV-2, there have been no clinical trials to assess their effectiveness and they are not routinely available in resource-limited settings. These limitations present major challenges to HIV-2 treatment, particularly in the areas in which it is most prevalent. This study is the 1st use of STRIBILD (elvitegravir (EVG), cobicistat (COBI), emtricitabine (FTC), tenofovir disoproxil fumarate (TDF)), an INI-based single tablet regimen, in HIV-2 infected adults in West Africa. The investigators hypothesize STRIBILD will be safe and effective as ART for HIV-2 infection. The Specific Aims of this study are: AIM 1: A pilot, open label, 48 week trial of STRIBILD (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) in 30 ARV-naïve HIV-2 Infected Adults in Dakar, Senegal. AIM 2: Determination of genotypic and phenotypic HIV-2 antiretroviral resistance in individuals with virologic failure (HIV-2 plasma RNA >250 copies/ml) participating in the 48 week trial of STRIBILD
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
- •Written informed consent
- •Age > 18 years old
- •HIV-2 Infection (confirmed by DetermineTM & Immunocomb II)
- •ARV-naïve
- •CD4 count < 750 cells/mm3 and/or WHO Stage 3 or 4 disease
- •Anticipate residing in Dakar area for duration of study
排除标准
- •Pregnancy or Breast feeding
- •HIV-1 or HIV-1/HIV-2 dual infection
- •Known allergy or contraindication to Elvitegravir, Cobicistat, Emtricitabine, or Tenofovir DF
- •Active Tuberculosis (STRIBILD contraindicated with rifampin)
研究组 & 干预措施
Open label prospective single arm study of Stribild
干预措施: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks (Drug)
结局指标
主要结局
Death
时间窗: 48 weeks
Number of Participants Experiencing Death within the study period
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
时间窗: 48 weeks
New WHO Stage 3 or 4 Event
时间窗: 48 weeks
New AIDS defining event per WHO criteria
次要结局
- Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF(48 weeks)
- Grade 3 or 4 Adverse Events(48 weeks)
- < 50 CD4 T-cell Increase at 48 Weeks From Baseline(48 weeks)
- CD4 T-cell Count at 48 Weeks < Baseline(48 weeks)
- Switching Off Stribild Prior to 48 Weeks(48 Weeks)
研究者
Geoffrey S. Gottlieb
Associate Professor, Medicine
University of Washington