ISRCTN42856592进行中（未招募）4 期
Switch from stable combined antiretroviral therapy containing abacavir/lamivudine or emtricitabine/tenofovir alafenamide plus dolutegravir or bictegravir to tenofovir disoproxil fumarate/lamivudine/doravirine in people living with HIV: Impact on lipids, body composition, insulin sensitivity, neuroendocrine function and inflammation markers
Chelsea and Westminster Hospital NHS Foundation Trust0 个研究点目标入组 60 人开始时间: 2022年9月21日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. HIV-1 infected, 18 years or older
- •2. On stable & suppressive triple cART for at least 6 months
- •3. No evidence of resistance to DOR, 3TC or TDF
- •4. No laboratory abnormalities, medical/psychiatric conditions or alcohol/drug use considered a barrier to participation by investigators
- •5. Women who are of childbearing potential and sexually active need to use the hormonal contraceptive methods, associated with inhibition of ovulation, listed in the protocol and detailed in Appendix IV of the protocol:
- •5.1. Implant
- •5.2. Depot injection
- •5.3. Intra-uterine device or system
- •5.4. Oral hormonal contraception
- •A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
- •Men who are sexually active and have partners who are women of childbearing potential must be using an adequate method of contraception to avoid pregnancy (male condom or sterilisation confirmed prior to the participant’s entry into the study) as described in Appendix IV of the protocol
排除标准
- •1. History of virological failure on a non-nucleoside reverse transcriptase inhibitors (NNRTI) in the absence of a post-failure genotypic resistance test proving the absence of resistance to DOR
- •2. History of virological failure on an 3TC and TDF in absence of a post-failure genotypic resistance test proving the absence of resistance to DOR (INSTI mutations that will lead to the need of administering DOR twice daily are considered as resistance to DOR – and the participant will be considered NOT eligible)
- •3. Concomitant medication contra-indicated with DOR, 3TC or TDF
- •4. Haemoglobin <9 g/dl
- •5. Platelets <80,000/mm³
- •6. Creatinine clearance <50 ml/min
- •7. AST or ALT =5N
- •8. Acute Hepatitis A infection
- •9. Concomitant DAA for anti-HCV therapy
- •10. Known acute or chronic viral hepatitis B or C
- •11. Individuals testing positive for HBcAb, but negative HBsAg/HBeAg, may be included in the trial
- •12. Individuals with positive anti-HCV results, but with HCV RNA not detected may be included in the trial
- •13. Pregnant or breastfeeding women, or individuals actively trying to conceive
- •14. History of osteoporosis or bone fractures/loss
- •15. Hypersensitivity to the active substance or to any of the excipients in tenofovir disoproxil fumarate, lamivudine and/or doravirine formulations
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