A Phase 3b, Randomized, Open-Label Study to Evaluate Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 60 Years
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 35
- 主要终点
- Percent Change From Baseline to Week 48 in Spine BMD
研究概览
简要总结
The primary objective of this study is to evaluate the safety of elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide (E/C/F/TAF) relative to unchanged current antiretroviral therapy (ART) by assessing spine and hip bone mineral density (BMD) measured at Week 48 in virologically-suppressed, HIV-1 infected participants aged ≥ 60 years.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Currently receiving a TDF and FTC or 3TC-containing 'backbone' (maximum 2 NRTIs) regimen plus a third agent for ≥ 6 consecutive months prior to screening visit. For individuals with 3 or more ART regimens, a regimen history must be provided for approval by the Sponsor.
- •Refer to assigned interventions for allowed third agents of the current regimen.
- •Documented plasma HIV-1 RNA levels < 50 copies/mL for ≥ 6 months preceding the screening visit (measured at least twice using the same assay). In the preceding 6 months prior to screening, one episode of "blip" (HIV-1 RNA > 50 and < 400 copies/mL) is acceptable, only if HIV-1 RNA is < 50 copies/mL immediately before and after the "blip".
- •Plasma HIV-1 RNA level < 50 copies/mL at screening visit
- •Adequate renal function
- •Estimated glomerular filtration rate ≥ 30 mL/min according to the Cockcroft-Gault formula (eGFRCG) and are on ARVs that are appropriately dose adjusted for renal function per package insert
- •All documented historical plasma genotype(s) must not show resistance to TDF or FTC, including, but not limited to the presence of reverse transcriptase resistance mutations K65R, K70E, M184V/I, or thymidine analog-associated mutations (TAMs) that include M41L, L210W, D67N, K70R, T215Y/F, K219Q/E/N/R. If historical plasma prior to first ART is not available or individual has 3 or more ART regimens, individuals will have proviral genotype analysis prior to Day 1 to confirm absence of archived resistance to TDF or FTC.
- •Study performed dual energy x-ray absorptiometry (DXA) scan and T-score received prior to Day 1
排除标准
- •Previous use of any approved or experimental integrase strand transfer inhibitor (INSTI) (for any length of time) if the current regimen contains a PI/r
- •Individuals will have no evidence of previous virologic failure on a PI/r or INSTI-based regimen (with or without resistance to either class of ARV)
- •A new AIDS-defining condition diagnosed within the 30 days prior to screening (except CD4+ cell count and/or percentage criteria)
- •Hepatitis C virus that would require therapy during the study
- •Individuals receiving ongoing treatment for bone disease (eg, osteoporosis), including bisphosphonates, denosumab, and strontium ranelate
- •Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
研究组 & 干预措施
E/C/F/TAF
Participants will switch from tenofovir disoproxil fumarate (TDF) and emtricitabine (FTC) or 3TC plus a third agent to E/C/F/TAF and will receive treatment for 48 weeks.
干预措施: E/C/F/TAF (Drug)
Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
干预措施: TDF (Drug)
Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
干预措施: FTC (Drug)
Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
干预措施: FTC/TDF (Drug)
Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
干预措施: 3TC (Drug)
Remain current regimen
Participants will remain on current TDF and FTC (or FTC/TDF) or 3TC plus continuing third agent.
干预措施: Third agent (Drug)
结局指标
主要结局
Percent Change From Baseline to Week 48 in Spine BMD
时间窗: Baseline; Week 48
Percent Change From Baseline to Week 48 in Hip BMD
时间窗: Baseline; Week 48
次要结局
- Percent Change From Baseline to Week 24 in Spine BMD(Baseline; Week 24)
- Percent Change From Baseline to Week 24 in Hip BMD(Baseline; Week 24)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 as Defined by the US FDA-Defined Snapshot Algorithm(Week 24)
- Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 as Defined by the US FDA-Defined Snapshot Algorithm(Week 48)
- Change From Baseline in CD4+ Cell Count at Week 24(Baseline; Week 24)
- Change in Baseline in CD4+ Cell Count at Week 48(Baseline; Week 48)