A Phase I Randomized, Placebo-controlled, Double-blind Study to Assess Safety, Pharmacokinetics, and Modeled Pharmacodynamics of a Vaginal Insert Containing Tenofovir Alafenamide and Elvitegravir

MATRIX-001 will examine the safety, PK, modeled PD, and acceptability of inserts containing the combination of TAF and EVG applied vaginally, daily for 3 days, then every other day for 14 days. The inserts are ultimately intended to be the basis of an event-driven, on-demand method for prevention of HIV and HSV sexual infection.

开始日期2023-11-08

申办/合作机构

Eastern Virginia Medical School

[+3]

PACTR202309578224660 / Suspended临床1期IIT

Phase 1 study to evaluate if broadly neutralizing monoclonal antibodies CAP256V2LS and VRC07-523LS, combined with antiretroviral therapy (ART), will result in sustained virological control following analytical treatment interruption.

开始日期2023-10-23

申办/合作机构

Centre for the AIDS Programme of Research in South Africa

NCT06135974 / Recruiting早期临床1期IIT

Phase 1 Trial of Multi-strain Lactobacillus Crispatus Vaginal Live Biotherapeutic Product

The goal of this randomized clinical trial is to evaluate safety and biologic effect of a multi-strain vaginal L. crispatus live biotherapeutic product (LBP) in people receiving antibiotic treatment for bacterial vaginosis (BV). The main question[s] it aims to answer are whether the intervention is safe, and whether the strains of L. crispatus will colonize recipients' vagina. The study will evaluate one LBP with 6 strains of L. crispatus (LC106) and one LBP with 15 strains (LC115) vs. placebo.
Participants will:
be treated with oral antibiotics for BV
receive 7 days of vaginal study product
collect daily home swabs and make short daily diary entries for 5 weeks, including the week of antibiotic treatment and the week of study product treatment.
Researchers will compare the 3 groups receiving different dosing strategies of LC106 and 1 group receiving LC115 vs. 1 group receiving placebo to see if the live biotherapeutic strains colonize the vagina after antibiotic treatment for BV.

开始日期2023-10-19

申办/合作机构

The Schwartz Center for Compassionate Healthcare

[+3]

100 项与 Centre for the AIDS Programme of Research in South Africa 相关的临床结果

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0 项与 Centre for the AIDS Programme of Research in South Africa 相关的专利（医药）

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585

项与 Centre for the AIDS Programme of Research in South Africa 相关的文献（医药）

2024-12-31·JOURNAL OF OBSTETRICS AND GYNAECOLOGY

Development of normal reference intervals for renal function in pregnancy: a secondary analysis of clinical trial data

Article

作者: Gray, Glenda ; Naidoo, Megeshinee ; Sebitloane, Motshedisi ; Lombard, Carl ; Legoabe, Zandile ; Moodley, Dhayendre

BACKGROUND:

Due to its potential nephrotoxicity, screening for pre-existing renal function disorders has become a routine clinical assessment for initiating Tenofovir diphosphate fumarate (TDF)-containing antiretroviral treatment (ART) or pre-exposure prophylaxis (PrEP) in pregnant and non-pregnant adults. We aimed to establish reference values for commonly used markers of renal function in healthy pregnant women of African origin.

METHODS:

Pregnant women ≥18 years, not living with HIV, and at 14-28 weeks gestation were enrolled in a PrEP clinical trial in Durban, South Africa between September 2017 and December 2019. Women were monitored 4-weekly during pregnancy until six months postpartum. We measured maternal weight and serum creatinine (sCr) at each visit and calculated creatinine clearance (CrCl) rates using the Cockcroft-Gault (CG) and Modification of Diet in Renal Disease (MDRD) formulae. Reference ranges for sCr and CrCl by CG and MDRD calculations were derived from the mean ± 2SD of values for pregnancy and postdelivery.

RESULTS:

Between 14--and 40 weeks gestation, 249 African women not exposed to TDF-PrEP contributed a total of 1193 renal function values. Postdelivery, 207 of these women contributed to 800 renal function values. The normal reference range for sCr was 30-57 and 32-60 umol/l in the 2^nd and 3^rd trimesters of pregnancy. Normal reference ranges for CrCl using the MDRD calculation were 129-282 and 119-267 ml/min/1.73m² for the 2^nd and 3^rd trimesters, respectively. Using the CG method of calculation, normal reference ranges for CrCl were 120-304 and 123-309 ml/min/1.73m² for the 2^nd and 3^rd trimesters respectively. In comparison, the normal reference range for sCr, CrCl by MDRD and CG calculations postpartum was 40-77 umol/l, 92-201, and 90-238 ml/min/1.73m², respectively.

CONCLUSIONS:

In African women, the Upper Limit of Normal (ULN) for sCr in pregnancy is approximately 20% lower than 6 months postnatally. Inversely, the Lower Limit of Normal (LLN) for CrCl using either MDRD or CG equation is approximately 35% higher than 6 months postnatally. We provide normal reference ranges for sCr and CrCl for both methods of calculation and appropriate for the 2^nd and 3^rd trimesters of pregnancy in African women.

2024-10-01·AIDS

Deconvoluting the contribution of antiretroviral choice in weight gain

Article

作者: Dawood, Halima ; Nicol, Melanie R. ; Hoy, Jennifer F.

2024-09-01·CLINICAL IMMUNOLOGY

Aberrant innate immune profile associated with COVID-19 mortality in Pretoria, South Africa

Article

作者: Moore, Penny L ; Rossouw, Theresa M ; Masenge, Andries ; de Beer, Zelda ; Abdullah, Fareed ; Casanova, Jean-Laurent ; Ueckermann, Veronica ; van der Mescht, Mieke A ; Anderson, Ronald ; Steel, Helen C ; Bastard, Paul

The African continent reported the least number of COVID-19 cases and deaths of all the continents, although the exact reasons for this are still unclear. In addition, little is known about the immunological profiles associated with COVID-19 mortality in Africa. The present study compared clinical and immunological parameters, as well as treatment outcomes in patients admitted with COVID-19 in Pretoria, South Africa, to determine if these parameters correlated with mortality in this population. The in-hospital mortality rate for the cohort was 15.79%. The mortality rate in people living with HIV (PLWH) was 10.81% and 17.16% in people without HIV (p = 0.395). No differences in age (p = 0.099), gender (p = 0.127) or comorbidities were found between deceased patients and those who survived. All four of the PLWH who died had a CD4+ T-cell count <200 cells/mm³, a significantly higher HIV viral load than those who survived (p = 0.009), and none were receiving antiretroviral therapy. Seven of 174 (4%) patients had evidence of auto-antibodies neutralizing Type 1 interferons (IFNs). Two of the them died, and their presence was significantly associated with mortality (p = 0.042). In the adjusted model, the only clinical parameters associated with mortality were: higher fraction of inspired oxygen (FiO2) (OR: 3.308, p = 0.011) indicating a greater need for oxygen, high creatinine (OR: 4.424, p = 0.001) and lower platelet counts (OR: 0.203, p = 0.009), possibly secondary to immunothrombosis. Overall, expression of the co-receptor CD86 (p = 0.021) on monocytes and percentages of CD8+ effector memory 2 T-cells (OR: 0.45, p = 0.027) was lower in deceased patients. Decreased CD86 expression impairs the development and survival of effector memory T-cells. Deceased patients had higher concentrations of RANTES (p = 0.003), eotaxin (p = 0.003) and interleukin (IL)-8 (p < 0.001), all involved in the activation and recruitment of innate immune cells. They also had lower concentrations of transforming growth factor (TGF)-β1 (p = 0.40), indicating an impaired anti-inflammatory response. The immunological profile associated with COVID-19 mortality in South Africa points to the role of aberrate innate immune responses.

项与 Centre for the AIDS Programme of Research in South Africa 相关的新闻（医药）

2024-09-20

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“诺奖风向标”2024拉斯克奖揭晓！陈志坚获奖，成为继屠呦呦、卢煜明之后又一位华人获奖者

撰文丨王聪 2011年，中国科学家屠呦呦因“发现青蒿素——一种用于治疗疟疾的药物，挽救了全球特别是发展中国家的数百万人的生命”而获得拉斯克奖临床医学奖。这让屠呦呦的贡献更为人所知，2015年，屠呦呦获得诺贝尔生理学或医学奖。拉斯克奖是美国最具声望的生物医学奖项，也是医学界仅次于诺贝尔奖的一项顶级大奖，该奖项创立于1946年，旨在表彰医学领域作出突出贡献的科学家、医生和公共服务人员。拉斯克奖素有“诺奖风向标”之称，例如，mRNA疫苗先驱Katalin Karikó和Drew Weissman于2021年获得了拉斯克奖临床医学奖，两年后就获得了诺贝尔生理学或医学奖。 2024年9月19日，2024年度拉斯克奖获奖名单揭晓。华人科学家陈志坚教授获得了拉斯克奖基础医学奖；三位GLP-1研究先驱 Joel Habener、Lotte Bjerre Knudsen、Svetlana Mojsov 获得了拉斯克奖临床医学奖； Quarraisha Abdool Karim、Salim S. Abdool Karim 获得了拉斯克奖公共服务奖。拉斯克奖基础医学奖获奖者：陈志坚（德克萨斯大学西南医学中心）获奖理由：发现感知自身和外源DNA的cGAS酶，解开了DNA如何刺激免疫和炎症反应的谜团（For the discovery of the cGAS enzyme that senses foreign and self DNA, solving the mystery of how DNA stimulates immune and inflammatory responses） 2024年拉斯克奖基础医学奖授予了陈志坚教授，以表彰他发现了能够感知自身和外源DNA的cGAS酶。在独到的思考和强有力的实验的推动下，陈志坚解开了DNA如何刺激免疫和炎症反应之谜。cGAS是哺乳动物对抗微生物入侵的主要机制的基础，它还能促进抗肿瘤免疫。在某些生理条件下，不适当的cGAS活性会导致自身免疫和炎症性疾病。该酶为多种人类疾病提供了药物靶点，它产生的信号分子有望用于对抗传染病和癌症。拉斯克奖临床医学奖获奖者：Joel Habener（麻省总医院）、Lotte Bjerre Knudsen（诺和诺德）、Svetlana Mojsov（洛克菲勒大学）获奖理由：发现和开发基于GLP-1的药物，彻底改变了肥胖的治疗（For the discovery and development of GLP-1-based drugs that have revolutionized the treatment of obesity） 2024年拉斯克奖临床医学奖授予了三位科学家，以表彰他们发现和开发基于GLP-1的药物，这些药物彻底改变了肥胖的治疗。Joel Habener和Svetlana Mojsov发现了GLP-1这种激素的生理活性形式，Lotte Bjerre Knudsen将其转化为促进减肥的药物（利拉鲁肽、司美格鲁肽）。全球有近9亿成年人患有肥胖症，过高的体重导致了多种危及生命的情况。肥胖通常被认为是意志力的失败，但对许多人来说，饮食和运动并不能解决这个问题。从历史上看，制造安全有效的药物来帮助人们减肥的尝试都失败了。而在他们三人的努力的，我们进入了体重管理的新时代，基于GLP-1的药物有望显著改善健康。拉斯克奖公共服务奖获奖者：Quarraisha Abdool Karim（南非艾滋病研究中心/哥伦比亚大学）、Salim S. Abdool Karim（南非艾滋病研究中心/哥伦比亚大学）获奖理由：阐明异性性传播HIV的主要驱动因素；采用拯救生命的方法来预防和治疗艾滋；以及在公共卫生政策和倡导方面的领导力（For illuminating key drivers of heterosexual HIV transmission; introducing life-saving approaches to prevent and treat HIV; and statesmanship in public health policy and advocacy） 2024年拉斯克奖公共服务奖授予Quarraisha Abdool Karim和Salim S. Abdool Karim，他们阐明了异性性传播HIV病毒的主要驱动因素，并介绍了预防和治疗艾滋病毒的挽救生命的方法。该奖项进一步表彰了他们在公共卫生政策和倡导方面的领导力。他们影响了全球的艾滋病项目，他们在发展南非的科学能力方面发挥了关键作用。在他们的职业生涯中，他们一直倡导科学及其造福世界公民的潜力。拉斯克奖华人获奖者此前共有5位华人科学家荣获拉斯克奖，分别是李卓皓（1962年基础医学奖）、李敏求（1972年临床医学奖）、简悦威（1991年临床医学奖）、屠呦呦（2011年拉斯克奖临床医学奖）、卢煜明（2022年拉斯克奖临床医学奖）。李卓皓，获奖理由：分离并鉴定脑垂体前叶中的六种激素李敏求，获奖理由：成功化疗治疗了妊娠期绒毛膜癌简悦威，获奖理由：开创性地使用重组DNA技术诊断人类遗传疾病，包括血红蛋白病。屠呦呦，获奖理由：发现青蒿素——一种用于治疗疟疾的药物，挽救了全球特别是发展中国家的数百万人的生命卢煜明，获奖理由：在母体血液中发现胎儿DNA，从而对唐氏综合症进行无创产前检测参考资料： https://laskerfoundation.org/winners/2024-winners/ 药渡媒体商务合作媒体公关 | 新闻&会议发稿张经理：18600036371（微信同号）点击下方“药渡“，关注更多精彩内容免责声明 “药渡”公众号所转载该篇文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请及时告知，我们会在24小时内删除相关信息。微信公众号的推送规则又双叒叕改啦，如果您不点个“在看”或者没设为"星标"，我们可能就消散在茫茫文海之中~点这里，千万不要错过药渡的最新消息哦！👇👇👇

疫苗信使RNA临床研究核酸药物

100 项与 Centre for the AIDS Programme of Research in South Africa 相关的药物交易

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100 项与 Centre for the AIDS Programme of Research in South Africa 相关的转化医学

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