ISRCTN37737787已完成未知
A randomised controlled trial to evaluate options for second-line therapy in patients failing a first-line 2 nucleoside reverse transcriptase inhibitors (2NRTI) and non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen in Africa
Medical Research Council (MRC) (UK)0 个研究点目标入组 1,200 人开始时间: 2009年9月22日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
2014 Results article in http://www.ncbi.nlm.nih.gov/pubmed/25014688 results 2017 Results article in http://www.ncbi.nlm.nih.gov/pubmed/28495562 observational analysis results 2018 Results article in http://www.ncbi.nlm.nih.gov/pubmed/29108797 follow-up results 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/36723505/ Substudy results (added 02/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Previously documented HIV infection on at least one standard antibody-based test
- •2. Aged 12 years and above, either sex
- •3. Taking 2NRTI + NNRTI-based regimen continuously for at least 12 months
- •4. Naive to protease inhibitor therapy
- •5. Good adherence to anti-retroviral therapy (ART) in the 12 weeks prior to screening defined as no more than 10% of doses missed (patients who do not have good adherence should be given adherence
- •counselling and re-assessed after an appropriate time interval of not less than 4 weeks)
- •6. Clinically stable and receiving treatment for any known opportunistic infections
- •7. HIV treatment failure defined by the one or more of the following clinical, immunological and virological criteria (modified from World Health Organization [WHO] 2006 criteria):
- •7.1. Clinical: A1 and A2 and A3 must be fulfilled:
- •A1: New or recurrent WHO stage 4 condition occurring after at least 12 months on ART
- •A2: CD4 cell count less than 200 cells/mm^3 after at least 12 months on ART, and confirmed at screening
- •A3: Viral load (VL) greater than 400 copies/ml at screening
- •7.2. Immunological: (B1 or B2 or B3) and B4 must be fulfilled:
- •B1: Fall of CD4 count to pre-therapy baseline (or below) after at least 12 months on ART and confirmed at screening
- •B2: Fall of CD4 count from previous value greater than 400 cells on treatment (x 2) to less than 200 cells/mm3 after at least 12 months on ART and confirmed at screening
- •B3: CD4 count less than 100 cells after at least 12 months on ART and confirmed at screening
- •B4: VL greater than 400 copies/ml at screening
- •7.3. Virological: VL greater than 10,000 copies/ml after at least 6 months on ART, and confirmed at screening after at least 12 months on ART
- •8. Willing and able to provide written informed consent
- •9. Able to attend for regular study follow-up visits
排除标准
- •1. Any major clinical contraindications to the use of bPI, the NRTIs that are available to be selected for a second-line regimen, or raltegravir
- •2. Known Hepatitis B carrier (Hepatitis B surface antigen positive)
- •3. Requirement for concomitant medication with known major interactions with study drugs for which drug substitutions or dose alterations are not available or acceptable
- •4. Currently receiving chemotherapy for malignancy
- •5. Women who are currently pregnant or breastfeeding
- •6. Current participation in another clinical trial involving a treatment intervention (may be permitted in some circumstances, but must first be discussed with the EARNEST chief investigator)
- •7. Life expectancy of less than one month in the opinion of the treating physician
研究者
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