Bone Evaluation in HIV-positive women over 40 who Switch from TDF + 3TC/FTC + NNRTI to Triumeq - BESTT Women's Study

King's College Hospital NHS Foundation Trust0 个研究点目标入组 90 人开始时间: 2016年1月15日最近更新: 2020年7月20日

适应症

试验速览

暂无简介。

•Documented HIV-1 antibody test
•Female aged >40 years
•Plasma HIV RNA < 50 copies/ml for at least twelve months on a stable regimen consisting of TDF/FTC plus an NNRTI
•Able to give informed consent
•HLA-B5701 negative
•Female patients of child-bearing potential must agree to use contraception for the duration of the study (more information in the protocol)
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 90

•Hepatitis B surface antigen positive (at any time since HIV diagnosis)
•Hepatitis C co-infection (HCV IgG negative, if HCV IgG positive must be HCV RNA negative)
•Known HIV resistance mutations to any of the study drugs
•Current or planned use of bisphosphonates
•Screening laboratory parameters =/> grade 3 (ACTG criteria – see appendix A)
•Creatinine clearance <50 mL/min (Cockcroft-Gault)
•Current alcohol use (>3 units daily for the past month) or drug dependence which would make the participant unable to comply with the protocol (investigator opinion)
•Active opportunistic infection within the last 4 weeks
•Significant co-morbidities (investigator opinion)
•Untreated hyperthyroidism (TSH below the lower limit of the normal range)
•Female patients of child-bearing potential who have/are:
•opositive pregnancy test at screening or during the study
•obreast feeding
•oplanning to become pregnant
•ounwilling to use adequate contraception throughout the study
•Individuals unable or unwilling to comply with the requirements of the study (investigator opinion).
•Hypersensitivity to any of the active substances or excipients
•Current or likely use of any of the following substances:
•oCarbamazepine, Oxcarbazine, Phenobarbitone, Phenytoin, St John’s Wort, dofetilide

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