PACTR202104807460491Other4 期
Switching virally suppressed HIV-1 infected elderly adults (age = 60 years) without prior confirmed virological failure from current anti-retroviral regimen to bictegravir, emtricitabine and tenofovir alafenamide (B/F/TAF)
niversity of Nairobi0 个研究点目标入组 516 人开始时间: 2021年3月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- Other
- 发起方
- 入组人数
- 516
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45 Year(s) 至 64 Year(s)（—）
- 性别
- All
入选标准
- •1. Able and willing to understand and comply with the protocol requirements, instructions and restrictions
- •2. Able and willing to give informed consent
- •3. Age 60 years or above
- •4. Documented HIV-1 infection as confirmed by HIV-antibody testing as per the Kenya National Guidelines
- •5. Has been receiving an ARV regimen for at least 24 weeks
- •6. Documented HIV-1 RNA viral load < 50 copies/ml at least 12 weeks prior to enrollment and no viral rebound between the first viral load < 50 copies/ml and the screening viral load
- •7. HIV-1 RNA viral load < 50 copies/ml at screening (within 28 days prior to enrollment)
排除标准
- •1. Confirmed treatment failure as defined by two consecutive HIV-1 RNA viral loads = 50 copies/ml separated by at least 2 weeks, after at least 6 months on ART or after a documented HIV-1 RNA viral load < 50 copies/ml
- •2. Documented HIV-2 infection
- •3. Using any concomitant therapy disallowed as per the reference safety information and product labeling for the study drugs
- •4. Has AST and/or ALT at least 5-times greater than the upper limit of normal
- •5. Has a CrCl below 50 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
- •6. Documented opportunistic infection within 4 weeks prior to the study enrolment
- •7. Investigator opinion that the patient should switch or discontinue any ARV in their current regimen immediately for clinical reasons (e.g. anemia with Hb < 9.5 g/dl while currently on AZT; HBsAg positive without currently being on TDF or TAF plus 3TC or FTC; experiencing adverse events associated with any ARV in current regimen deemed significant enough to warrant immediate change in regimen)
- •8. Any condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the study
- •9. History or presence of allergy to the study drugs or their components
- •10. BMD monitoring population will also exclude any subject with a pre-existing condition which is likely to decrease validity of bone mineral density estimations (including pre-existing vertebral or bilateral hip fractures, lytic or blastic metastases, bilateral hip arthroplasty, or lumbar spine internal fixation)
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