Background: Retention in clinical trials is critical for the accumulation of data over time and retaining enough power for comprehensive analysis. We document for the first time the retention rates and factors associa...Background: Retention in clinical trials is critical for the accumulation of data over time and retaining enough power for comprehensive analysis. We document for the first time the retention rates and factors associated with retention among a cohort of HIV exposed seronegative (HESN) person in a discordant relationship. Understanding these factors will provide valuable cues for maintaining high retention rates in future HIV biomedical prevention studies in this cohort. Aim: We aimed to document retention rates and associated factors relevant in conducting future HIV prevention studies using a cohort of HIV exposed sero-negative individuals. Method: We conducted a prospective cohort study to enroll HESN persons in discordant relationship based on established inclusion criteria that includes: Established sero-discordance with at least 3 months in the relationship;above 18 years and willingness to be followed up. Relevant ethical approvals were obtained. Following informed consent at enrollment, standardized questionnaires on risk behavior and factors that may affect retention were administered at enrollment and during the 2 years follow-up. This was spread over 10 follow-up visits to mimic phase a 2b HIV vaccine clinical trial follow up and duration. In addition, clinical examinations were done and samples collected for safety lab during the follow up visits. Estimation of CD4 and viral load was also done for the HIV+ partners of HESN study participants. Results: Six hundred and sixty HESN persons were screened and 534 (81%) enrolled (i.e. month 0) and followed up. There was a decline in retention from 96% at month 1 (visit 1) to 78% at month 24 (Visit 10). Sharpest drop out from the study occurred at month 1 (20%) and month 15 (14%) follow-up visits. Inability to reach study participants, unwillingness of study participants to continue study, and mortality of the HIV+ partners of HESN participants were the commonest reasons for participant study termination. Furthermore, no or low level of formal education, (AOR 展开更多
Oncogenic osteomalacia (OOM) is an uncommon metabolic and bone disease caused by fibroblast growth factor 23 (FGF23), a phosphaturic factor produced by phosphaturic mesenchymal tumors (mixed connective tissue variant,...Oncogenic osteomalacia (OOM) is an uncommon metabolic and bone disease caused by fibroblast growth factor 23 (FGF23), a phosphaturic factor produced by phosphaturic mesenchymal tumors (mixed connective tissue variant, PMTMCTV) characterized by phosphate leakage from kidneys and subsequent hypophosphatemia. In this paper, we present the case of a patient, 42-year-old woman affected by left side limp and pain involving lumbar spine, pelvis and hip joints, referred to the Rheumatology Department of our Hospital for the treatment of a suspected sero-negative spondilo-arthritis. During hospitalization patient began an immuno-suppressive therapy with TNF-alpha inhibitors associated with Pamidornate, Indometacin, Esomeprazole and vitamin D3. Nevertheless pain did not decrease and a new examination found a worst hypophosphatemia (1 mg/dl) with normal Ca and PTH’s plasma values. During the same check-up a painful bulge on the anterior part of the right knee was observed and the Magnetic Resonance Imaging scan revealed an ovular solid lesion in the soft tissue closed to the upper part of the patella. Histological analysis identified the lesion as a PMTMCTV. After surgical removal patient got complete recovery. We will discuss about diagnostic evaluation, differential diagnosis and treatment.展开更多
目的了解经性传播途径高暴露不易感人群淋巴细胞亚群的差异,分析其与艾滋病病毒Ⅰ型(HIV-1)不易感的关系,探讨经性途径高暴露HIV不易感的免疫基础。方法收集37例经性传播途径高暴露HIV-1持续血清阴性者(Highly exposed and persistently...目的了解经性传播途径高暴露不易感人群淋巴细胞亚群的差异,分析其与艾滋病病毒Ⅰ型(HIV-1)不易感的关系,探讨经性途径高暴露HIV不易感的免疫基础。方法收集37例经性传播途径高暴露HIV-1持续血清阴性者(Highly exposed and persistently remain seronegative,简称HEPS人群)、65例HIV-1感染者(简称HIV阳性人群)及128例健康对照人群(简称HC人群)的抗凝全血,用流式细胞仪检测相关淋巴细胞亚群,并分析其相关性。结果HEPS人群与HC人群外周血淋巴细胞亚群差异没有统计学意义;HIV阳性人群外周血CD4+T淋巴细胞数量、CD4/CD8比值显著低于HEPS和HC两组人群(P<0.001),CD8+T淋巴细胞数量则显著高于该两组人群(P<0.001);HIV阳性人群外周血CD1+9B淋巴细胞、CD1+6CD5+6NK细胞数量显著低于HEPS人群和HC人群。HEPS人群的CD1+9B淋巴细胞数量与CD4+、CD8+T淋巴细胞数量呈显著正相关,而CD1+6CD5+6NK细胞数量与其CD4+、CD8+T淋巴细胞数量无相关性。结论经性途径高暴露HIV-1持续血清阴性人群的淋巴细胞亚群,和健康对照人群比较无显著性差异,HIV感染可明显降低CD4+T淋巴细胞、CD1+9B淋巴细胞和CD1+6CD5+6NK细胞数量。展开更多
文摘Background: Retention in clinical trials is critical for the accumulation of data over time and retaining enough power for comprehensive analysis. We document for the first time the retention rates and factors associated with retention among a cohort of HIV exposed seronegative (HESN) person in a discordant relationship. Understanding these factors will provide valuable cues for maintaining high retention rates in future HIV biomedical prevention studies in this cohort. Aim: We aimed to document retention rates and associated factors relevant in conducting future HIV prevention studies using a cohort of HIV exposed sero-negative individuals. Method: We conducted a prospective cohort study to enroll HESN persons in discordant relationship based on established inclusion criteria that includes: Established sero-discordance with at least 3 months in the relationship;above 18 years and willingness to be followed up. Relevant ethical approvals were obtained. Following informed consent at enrollment, standardized questionnaires on risk behavior and factors that may affect retention were administered at enrollment and during the 2 years follow-up. This was spread over 10 follow-up visits to mimic phase a 2b HIV vaccine clinical trial follow up and duration. In addition, clinical examinations were done and samples collected for safety lab during the follow up visits. Estimation of CD4 and viral load was also done for the HIV+ partners of HESN study participants. Results: Six hundred and sixty HESN persons were screened and 534 (81%) enrolled (i.e. month 0) and followed up. There was a decline in retention from 96% at month 1 (visit 1) to 78% at month 24 (Visit 10). Sharpest drop out from the study occurred at month 1 (20%) and month 15 (14%) follow-up visits. Inability to reach study participants, unwillingness of study participants to continue study, and mortality of the HIV+ partners of HESN participants were the commonest reasons for participant study termination. Furthermore, no or low level of formal education, (AOR
文摘Oncogenic osteomalacia (OOM) is an uncommon metabolic and bone disease caused by fibroblast growth factor 23 (FGF23), a phosphaturic factor produced by phosphaturic mesenchymal tumors (mixed connective tissue variant, PMTMCTV) characterized by phosphate leakage from kidneys and subsequent hypophosphatemia. In this paper, we present the case of a patient, 42-year-old woman affected by left side limp and pain involving lumbar spine, pelvis and hip joints, referred to the Rheumatology Department of our Hospital for the treatment of a suspected sero-negative spondilo-arthritis. During hospitalization patient began an immuno-suppressive therapy with TNF-alpha inhibitors associated with Pamidornate, Indometacin, Esomeprazole and vitamin D3. Nevertheless pain did not decrease and a new examination found a worst hypophosphatemia (1 mg/dl) with normal Ca and PTH’s plasma values. During the same check-up a painful bulge on the anterior part of the right knee was observed and the Magnetic Resonance Imaging scan revealed an ovular solid lesion in the soft tissue closed to the upper part of the patella. Histological analysis identified the lesion as a PMTMCTV. After surgical removal patient got complete recovery. We will discuss about diagnostic evaluation, differential diagnosis and treatment.
