ISRCTN11504121已完成4 期
The metabolic impact of darunavir/ritonavir maintenance monotherapy after successful viral suppression with standard Atripla in HIV-1 infected patients: an unblinded, multicentre, randomised controlled trial
Guy's & St. Thomas' NHS Foundation Trust (UK)0 个研究点目标入组 70 人开始时间: 2010年11月12日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
研究概览
简要总结
- 2016 results of the effects on vitamin D, bone and the kidney when switching from fixed-dose tenofovir disoproxil fumarate/emtricitabine/efavirenz to darunavir/ritonavir monotherapy, in https://www.ncbi.nlm.nih.gov/pubmed/26460504 (added 21/01/2019) 2. 2016 results of switching from Atripla to darunavir/ritonavir Monotherapy on neurocognition, quality of life, and sleep, in https://www.ncbi.nlm.nih.gov/pubmed/27216134 (added 21/01/2019) 3. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27898597 (added 21/01/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Between 18-65 Males and Females
- •2. Documented Positive HIV-antibody test and previous positive HIV-antibody test within three months of the start of the study
- •3. Plasma HIV RNA <50 copies/ml for at least six months on Atripla
- •4. Agree to NOT take vitamin D supplements for the duration of the study
- •5. Willing to use barrier contraception (condoms) for the duration of their participation in the study
- •6. Ability to give informed consent
排除标准
- •1. Pregnancy or breast feeding
- •2. Patient unlikely to comply with protocol, and in particular adhere to therapeutic regimen
- •3. Patient likely to use narcotics during the study period
- •4. Hepatitis B co-infection (past or present)
- •5. Diabetes mellitus
- •6. Received vitamin D supplementation for more than one month within the previous 6 months
- •7. Current use or likely to require use of concomitant medication with known interactions with Darunavir or Ritonavir including rifampicin, amiodarone, flecainide, bupropion, clozapine, ergotamine, mexilitine, midazolam, pethidine, pimoziide, quinidine, sertindole, sildanefil, voriconazole, zolpidem, and St. John?s Wort would exclude a subject from the trial
- •8. Individuals experiencing side effects from their current regime will not be excluded from analysis
研究者
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