PACTR202404870570433尚未招募3 期
Efficacy, Safety and Tolerability of Switching to DTG/3TC Single Tablet Regimen from B/F/TAF in Older Persons Living with HIV in Kenya
niversity of Nairobi0 个研究点目标入组 240 人开始时间: 2024年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
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. Have been randomised to the B/F/TAF arm and completed the B/F/TAF-elderly study. Participant should be on B/F/TAF until day 1 of entry into the current study
- •4. 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. Using any protocol-defined prohibited medicine where the participant is unwilling or unable to switch to an alternative
- •3. Evidence of hepatitis B virus (HBV) infection based on the results of testing at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBc), hepatitis B surface antibody (anti-HBs) and HBV DNA
- •4. Has AST and/or ALT at least 5-times greater than the upper limit of normal
- •5. Severe hepatic impairment (Class C) as determined by Child-Pugh classification
- •6. Has a CrCl below 30 ml/min (as estimated using the Cockcroft-Gault estimate for glomerular filtration rate)
- •7. Documented opportunistic infection within 4 weeks prior to the study enrolment
- •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. Untreated syphilis infection (positive rapid plasma reagin [RPR] at Screening without clear documentation of treatment). Participants who are at least 7 days post completed treatment are eligible.
- •10. History or presence of allergy or intolerance to the study treatment or their components or drugs of their class or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
- •11. Ongoing malignancy other than cutaneous Kaposi’s sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia.
- •12. Participants who in the investigator’s judgment, poses a significant suicidality risk
- •13.Any evidence of any major 3TC resistance associated mutations (M184V/I and/or K65R and/or MDR) or presence of any major INSTI resistance associated mutation
研究者
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