Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:
* Arm 1 will receive standard daily oral ART.
* Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
* Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
* Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
* Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.

开始日期2023-11-28

申办/合作机构

Columbia University

[+1]

NCT05495204

/ CompletedN/A

External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

开始日期2022-08-05

申办/合作机构

Epividian, Inc.

[+1]

NCT05388474

/ RecruitingN/A

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end.
Primary Objective:
To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab.
Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment.
To assess the long-term safety and tolerability of ibalizumab.
Other Objectives:
To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.

开始日期2022-03-22

申办/合作机构

Theratechnologies, Inc.

[+2]

100 项与艾巴利珠单抗相关的临床结果

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100 项与艾巴利珠单抗相关的转化医学

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100 项与艾巴利珠单抗相关的专利（医药）

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项与艾巴利珠单抗相关的文献（医药）

2025-03-01·AIDS

Emerging integrase resistance in an international perinatal virtual clinic

Article

作者: Foster, Caroline ; Mackie, Nicola E. ; Lyall, Hermione ; Bailey, Angela ; Tickner, Neil ; Glenn, Jessica ; Welch, Steven ; Milheiro Silva, Tiago ; Bamford, Alasdair ; Simon, Katie ; Levin, Leon ; Kenny, Julia ; Turkova, Anna ; Eni-Olotu, Ayolola

Objective::

The aim of this study was to identify the prevalence of emergent integrase drug resistance mutations (INSTI-DRMs) in international referrals to a perinatal virtual clinic (PVC).

Design::

A retrospective cohort study.

Setting::

Monthly multidisciplinary PVC reviewing complex case management for children and adolescents with perinatally acquired HIV (CAWHIV).

Participants::

One hundred fourteen cases referred for virological failure between October 2018 and January 2024.

Main outcome measures::

Data collected included age, sex, weight, country of residence, antiretroviral therapy (ART) history, HIV viral load, CD4+ cell count, and comorbidities. Resistance mutations were interpreted using the Stanford HIV Drug Resistance database with emergent major INSTI-DRMs described.

Results::

Of 114 referrals, 103 (90%) had resistance sequences available. Prior INSTI exposure was documented in 61/103 (59%) with 19/61 (31%) having INSTI-DRMs. For these 19, median (IQR) age was 11 years (6–14), weight 25 kg (17–50), CD4+ cell count 485 cells/μl (153–805), and viral load 84 000 copies/ml (2380–137 000). Twelve of 19 (65%) were from low/middle-income countries (LMIC), 6/19 (32%) had current AIDS diagnoses with 14/19 (74%) referred from 2022 onwards. There were a median three prior regimens with 13/19 (68%) having at least 3 class resistance. Two developed INSTI-DRMs on first-line dolutegravir (DTG)-based ART, 17 on second+ line therapy. PVC recommendations were for tenofovir+ lamivudine/emtricitabine (six split adult tablets) with boosted darunavir [19; six twice daily (b.i.d.)], with b.i.d. DTG (6), plus fostemsavir (1) and ibalizumab (1).

Conclusion::

Although uncommon, INSTI resistance is emerging, mainly in highly treatment experienced CAWHIV from LMIC, highlighting the global need for access to boosted protease inhibitors and novel classes, including formulations for children less than 35 kg.

2025-02-01·VIROLOGY

Investigating the combination of Temsavir and entry inhibitors on HIV replication: Synergistic and antagonistic effects observed against various R5-tropic envelopes

Article

作者: Wang, Lingyun ; Su, PeiYi ; Yukselten, Yunus ; Akang, Edidiong ; Sutton, Richard E

HIV is still a pandemic; antiretroviral therapeutics for preventing and treating HIV infection continue to present significant challenges. The demand for new drugs and effective treatments remains ongoing. Here, we investigated the effects of combining Temsavir with other HIV entry inhibitors, including CD4 mimetic BNM-III-170, T20 or enfuvirtide, Ibalizumab, and Maraviroc. Our results show that TMR demonstrates both synergistic and antagonistic activity when combined those other entry inhibitors, depending on the concentration and the specific envelope used. Results suggest that while low-dose combinations, especially using Temsavir and CD4 mimetic, exhibited antagonistic effects, Temsavir showed synergy at low and medium concentrations in combination with enfuvirtide, Ibalizumab, and Maraviroc. These results are promising for the potential of co-administrating antiretrovirals for HIV treatment and highlights the importance of developing advanced antiviral strategies. On the other hand, the variable responses against different R5-tropic envelopes underscore the complexity of designing universally effective combination antiviral therapies.

2024-12-15·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Efficacy and Safety of 2 Fixed Doses of Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced HIV-Positive Individuals

Article

作者: DeJesus, Edwin ; Anstett, Kaitlin ; Gathe, Joseph C ; Towner, William J. ; Cash, R. Brandon

Background::

Sustained viral suppression in patients with multidrug-resistant (MDR) HIV infection remains difficult; accordingly, agents targeting different steps in the HIV life cycle are needed. Ibalizumab, a humanized immunoglobulin G4 monoclonal antibody, is a cluster of differentiation (CD4)-directed postattachment inhibitor.

Methods::

In this phase 2b study, 113 patients with MDR HIV-1 and limited treatment options were assigned an optimized background regimen (OBR) and randomized to either 800 mg ibalizumab every 2 weeks (q2wk; n = 59) or 2000 mg ibalizumab every 4 weeks (q4wk; n = 54) up to week 24.

Results::

Viral loads (VL) below the detection limit were achieved in 44% and 28% of patients in the 800 mg q2wk and 2000 mg q4wk groups, respectively, at week 24. Mean (SD) VL (log10 copies/mL) decreased from Baseline [4.6 (0.8), 800 mg q2wk; 4.7 (0.7), 2000 mg q4wk] to week 2, with the reduction maintained through week 24 [2.9 (1.5), 800 mg q2wk; 3.2 (1.4), 2000 mg q4wk]. Baseline CD4+ counts were 80.5 and 54.0 cells/μL in the 800 mg q2wk and 2000 mg q4wk groups, respectively. Mean CD4+ T-cell count was increased at week 24 in both groups. No serious adverse events were related to ibalizumab.

Conclusions::

In heavily treatment-experienced patients with HIV (PWH) at a more advanced baseline disease severity, clinically significant response rates at week 24 were achieved with ibalizumab plus OBR. Ibalizumab's unique mechanism of action and lack of cross-resistance to other antiretroviral agents make it an important component of combination treatment regimens for PWH with limited treatment options.

项与艾巴利珠单抗相关的新闻（医药）

2025-03-17

·PRNewswire

TaiMed Biologics Announces Results from Late-Breaking Phase 2a Data on Long-Acting HIV Maintenance Therapy at CROI 2025

TMB-365/TMB-380 Combination Demonstrates Viral Suspension Without the Need for Susceptibility Screening TaiMed Biologics will reshape HIV treatment management and seeks strategic collaborations with global pharmaceutical partners for the commercialization of its long-acting HIV maintenance therapy TAIPEI, March 17, 2025 /PRNewswire/ -- TaiMed Biologics (4147 TWO), an innovation-driven biotech company, has Phase 2a clinical study evaluating TMB-365/TMB-380 long-acting dual bNAb regimen for HIV maintenance therapy. This regimen, which is the first of its kind, offers a viable alternative to daily oral cART for individuals living with HIV. Continue Reading Key findings from the trial include durable viral suppression, with 94% of participants maintaining RNA levels below 50 copies/mL throughout the treatment period, while only the remaining 6% of participants recorded viral load of 59 copies/mL at end of 24-week treatment. No pre-defined virologic failure, which were defined as two consecutive viral load measurements above 50 copies/mL. The treatment was well-tolerated, with no serious adverse events, no Grade 3 or Grade 4, or acute infusion reactions reported. Additionally, no participants experienced treatment-limiting immune responses to the combination therapy. One of the more remarkable findings of TMB-365/TMB-380 is that it does not require susceptibility screening as the combination's broad breadth of activity and high potency, participants were not pre-screened for susceptibility to either bNAb featured for lowering the barrier to treatment access and ensures a wider range of individuals living with HIV can benefit from the therapy. Additionally, the pharmacokinetic (PK) and immunological markers also support the potential for long-acting viral suppression and stable immune function. This Phase 2a clinical trial was not a double-blind placebo-controlled study, and therefore, no statistical p-values were reported. "We are honored that our study was accepted for late-breaking presentation at CROI, highlighting the high scientific merit and groundbreaking nature of our results among numerous research studies, TMB-365/TMB-380 is the first long-acting mAb combination to achieve a high rate of viral suppression without screening requirements with robust potency, broad coverage and low resistance risk The regimen aims to reduce the frequency of daily dosing, while maintaining treatment's efficacy," said Dr. Jimmy Chang, CEO of TaiMed Biologics. "The global HIV treatment market valued at approximately USD 30 billion annually, with long-acting treatments currently account for only 3% but are projected to increase to over 30-40% in the coming years. The outstanding Phase 2a results position TMB-365/TMB-380 as a frontrunner in this rapidly growing sector, offering clear advantages over existing long-acting treatment options," emphasized by Dr. Jimmy Chang. TaiMed Biologics is actively seeking strategic collaborations with global pharmaceutical partners to support the commercialization of TMB-365/TMB-380. TaiMed Biologics welcomes opportunities to explore potential collaborations with global pharmaceutical partners to advance the commercialization of TMB-365/TMB-380 For more information, please contact: Jonathan Ho, [email protected]. About TaiMed Biologics Founded in 2007, TaiMed Biologics (4147.TWO) is a leading commercial-stage biotechnology company focused on developing innovative therapies for HIV treatment. The company successfully launched ibalizumab (Trogarzo®), the world's first and only FDA-approved monoclonal antibody for HIV and continues to pioneer long-acting biologics and antibody-drug conjugates (ADCs). TaiMed Biologics also offers comprehensive contract development and manufacturing (CDMO) services and is publicly traded on the OTC Market since November 2015, currently part of the MSCI Small Cap Index. SOURCE TaiMed Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期上市批准

2025-03-12

·GlobeNewswire-Health Care

Theratechnologies Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI

Results show similar levels of virus undetectability in patients on ibalizumab-containing regimens as in controls, despite greater baseline severity of HIV Ibalizumab continues to demonstrate long-term efficacy and safety as part of combination antiretroviral therapy in heavily treatment-experienced people with multidrug resistant HIV MONTREAL, March 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV. In a poster session at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, Calif., investigators from the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) reported that patients treated with regimens containing ibalizumab achieved undetectable HIV viral load levels at similar rates as those receiving non-ibalizumab-containing regimens, despite displaying characteristics indicative of more severe HIV disease at baseline. “The availability of long-term injectable therapies has not eliminated the phenomenon of multidrug resistance, and heavily treatment-experienced people with HIV deserve fully suppressive antiretroviral regimens that can help them establish and maintain virologic control,” stated presenting author Smitha Gudipati, MD, an infectious disease specialist at Henry Ford Hospital in Detroit, Mich. “We are therefore encouraged to see such impressive reductions in viremia in patients whose regimens include ibalizumab, despite having lower CD4 counts and higher viral loads at baseline than the non-ibalizumab control group.” Theratechnologies previously announced the study design and baseline characteristics of participants in PROMISE-US (ClinicalTrials.gov identifier: NCT05388474), a phase 4, multicenter, retrospective and prospective, observational, non-interventional registry study. The trial is designed to assess risk factors and predictors of virologic and immunologic response in HTE people with HIV (PWH) and specific sub-populations. Its primary objective is to evaluate the long-term efficacy and durability of ibalizumab, a CD4-directed post-attachment inhibitor of HIV, in combination with other antiretroviral therapies by comparing the clinical outcomes of patients receiving ibalizumab (Cohort 2) versus matched patients not receiving ibalizumab (Cohort 1). At CROI, the PROMISE-US investigators presented an interim, unmatched subgroup analysis comprising 112 participants, of whom 70 were enrolled in Cohort 1 and 42 in Cohort 2. At baseline, 27 of participants in Cohort 1 and 25 in Cohort 2 were viremic, defined as viral load above 50 RNA copies/mL (39% and 57%, respectively; p=0.0279). Three-quarters (74%) of participants in Cohort 1 who had baseline viremia had more than 200 CD4 T-cells/mm3 at baseline, compared to only 44% of those in Cohort 2 who were viremic at baseline (p=0.0376). Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). Ibalizumab was well-tolerated with no infusion reactions reported and no discontinuation of treatment by participants in Cohort 2 due to a treatment emergent adverse event. “The PROMISE-US trial is the first registry to capture long-term clinical outcomes for highly treatment-experienced patients with multidrug-resistant HIV in a real-world setting and in the US specifically,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “The data presented today suggest that ibalizumab can be a critical component of therapeutic regimens in the modern antiretroviral era. We look forward to validating these interim findings as we continue to enroll and monitor patients in this ongoing study.” About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the long-term safety and efficacy of ibalizumab, the effect of ibalizumab on the reductions of viremia and the use of ibalizumab as a component of therapeutic regimens in the modern antiretroviral era. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the fact that patients receiving ibalizumab will achieve undetectable HIV viral load levels. The Company refers current and potential investors to the “Risk Factors” section of its Annual Information Form filed under the Company’s Form 20-F dated February 26, 2025 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com1-551-261-0401

临床结果临床3期临床2期

2025-02-08

·药时空

申联生物跨界布局，顺势进军人用创新药领域

2025年2月6日，申联生物（688098）正式发布对外投资公告，旗下全资子公司上海本天成生物医药有限公司斥资6000万元，将取得创新药企业扬州世之源生物科技有限责任公司20.48%的股权。这一战略举措标志着申联生物正式进军人用创新药领域，在生物科技行业发展的征程中迈出了重要一步。世之源是一家专注于创新药开发与生产的高科技企业，搭建了先进的单抗垂直整合平台，目前拥有三款在研新药在中国大陆的商业化权益，包括创新抗过敏 Anti-IgE 单克隆抗体药物 (UB-221)、艾滋病治疗单克隆抗体药物 (UB-421) 以及抗单纯疱疹病毒单克隆抗体药物 (UB-621)。三款新药已在多个国家和地区完成了不同阶段的研究，展现出了良好的市场前景和临床价值。其中，艾滋病治疗单克隆抗体药物（UB-421）从台湾联合生物制药股份有限公司（UBP）获得授权并引进中国大陆，该新药由美国联合生物医学公司（UBI）原研研发。2025年1月3日，UB-421的研究成果在自然-医学期刊(Nature Medicine)刊登。这篇原创论文中的受试患者对多数抗逆转录病毒药物、广谱中和抗体及中裕新药的Trogarzo(抗CD4第2结构域抗体)均具有高度的耐药性，并患有卡波西氏肉瘤。研究团队发现，患者T细胞上CD4的第1结构域在整个研究期间皆被UB-421抗体完全占据，HIV病毒无法进入患者宿主细胞进行病毒基因复制，因此在整个长达48周的研究期间都没有观察到病毒耐药突变发生。研究发现，患者表现出对UB-421输注有良好的耐受性，没有发生任何不良事件，CD4+T细胞数也显著增加而HIV储存库减少。这些成果显示了UB-421能以直接作用或辅助药物的形式，用于治疗携带多重耐药或泛耐药病毒的病患，在艾滋治疗史上具有重大意义，可说是一种划时代的新医疗方案。艾滋病（AIDS）是由人类免疫缺陷病毒（HIV）引起的全球性公共卫生难题。UB-421作为一种创新的抗HIV单克隆抗体药物，通过靶向宿主CD4受体，提供了一种全新的治疗策略。其具备广谱抗病毒活性、长效性和高安全性的特点，为艾滋病治疗领域带来重要突破。未来，UB-421有望在耐药患者管理、简化治疗方案以及功能性治愈研究中发挥重要作用，为HIV感染者带来新的希望。申联生物作为全球首家将合成肽技术应用于兽用生物制品并实现大规模商业化推广的企业，在生物大分子医药领域已经建立起了一套完整且领先的技术体系。尤其在长链肽技术合成方面处于全球领先地位，已具备长达100个氨基酸以上的超长链的固相合成技术、高度模拟天然结构的空间构象构建技术、公斤级稳定的规模化量产技术等显著优势。公司也是全球兽用生物制品领域首个环状mRNA技术的应用实践企业，已具备全工艺链自主知识产权体系，突破现有技术壁垒。同时，公司积极利用基因工程技术精准开发宠物治疗性单抗，已具备宠物特有靶点的筛选及抗体设计、制备能力。此次进军人用创新药领域，是申联生物基于自身技术优势做出的重大战略决策，更是申联生物发展历程中又一个重要里程碑。通过本次与世之源的深度合作，申联生物能够将自身前沿的生物技术及生产优势进一步延伸应用，并与世之源的创新药研发能力相结合，实现技术与资源的高效整合，进一步拓展业务版图，提升综合竞争力，强化市场地位。未来，公司将凭借在前沿生物技术平台和疫苗制备工艺方面的显著优势，在经济动物生物制品领域持续精耕细作，在伴侣动物领域积极拓展版图，在人用生物制品领域不断开拓创新。通过多领域协同发展，逐步成长为世界一流的高科技集团化生物公司，为增进人类健康福祉、提升动物福利贡献更大力量。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

临床1期

100 项与艾巴利珠单抗相关的药物交易

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外链

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	美国	Theratechnologies, Inc.	2018-03-06

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05388474 (PROMISE-US, Company_Website) 人工标引	临床4期	HIV感染	112	matched patients not receiving ibalizumab (Cohort 1)	蓋鑰蓋壓窪觸鹽獵築築(構壓淵壓築鹹鹽觸膚範) = Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). 簾獵網淵網鹽鹹積網鏇 (鏇觸繭鏇餘構廠廠繭衊 ) 更多	积极	2025-03-12
				ibalizumab (Cohort 2)
Biospace 人工标引	临床2/3期	HIV感染	76	ibalizumab 800 mg	範艱鏇窪艱網艱憲糧繭(鹽選簾簾夢憲鑰膚網憲): 1.98 (95% CI, 1.02 ~ 3.69) 更多	积极	2023-07-12
				non-ibalizumab-containing regimens
NCT00089700 (Pubmed \| J Acquir Immune Defic Syndr)	临床2期	HIV感染	82	Ibalizumab 15 mg/kg q2wk	齋壓艱壓糧衊醖願簾鹹(餘簾夢蓋願觸蓋繭積齋) = No ibalizumab-related serious adverse events were reported 獵獵壓糧齋衊膚獵鬱積 (鏇築鏇齋遞淵膚繭製憲 )	积极	2021-04-01
				Ibalizumab 10 mg/kg weekly for 9 weeks, then q2wk
NCT02707861 (CTgov)	临床3期	HIV感染	79	Optimized Background Regimen+ibalizumab (Cohort 1)	遞構鑰艱襯廠鑰窪製獵 = 壓膚願夢鏇願窪壓願鑰遞衊網選構壓鬱壓鑰齋 (獵鹹廠選襯窪糧憲顧淵, 顧製廠餘網鑰築鹽糧構 ~ 遞鏇繭願餘網顧襯襯構) 更多	-	2021-03-11
				Optimized Background Regimen+ibalizumab (Cohort 2)	遞構鑰艱襯廠鑰窪製獵 = 築遞蓋蓋壓夢構襯憲網遞衊網選構壓鬱壓鑰齋 (獵鹹廠選襯窪糧憲顧淵, 憲衊鏇繭糧壓餘繭簾鬱 ~ 衊艱選鹹願製簾鹹觸觸) 更多
TMB-301/TMB-311 (IAS2021)	N/A	HIV血清阳性	40	Ibalizumab	淵窪選築廠範淵構鏇製(艱糧鏇築積獵壓襯觸鏇) = 鑰淵襯窪蓋製醖鏇窪選製製襯築蓋窪齋醖蓋廠 (鹽鬱顧襯簾壓構鏇簾繭, -3.28 4.57)	-	2021-01-01
NCT02475629 (CTgov)	临床3期	HIV感染	40	Optimized Background Regimen (OBR)+ibalizumab	膚範蓋鹽鬱鹽製觸艱獵 = 壓蓋築築淵壓艱衊壓齋餘夢觸範網醖餘構鹹夢 (蓋窪鹽壓製壓膚選顧鹹, 糧遞蓋簾醖淵構構網蓋 ~ 遞襯糧衊網範淵願糧衊) 更多	-	2020-03-19
IAS2019	N/A	HIV感染	-	Ibalizumab plus OBR	網憲選壓糧鹽醖憲淵壓(鑰廠願鹹膚繭艱鹽製衊) = 遞壓顧鹽廠膚觸餘繭遞網構艱醖鬱鹽廠積憲鏇 (艱構襯鹽糧淵壓觸膚顧 ) 更多	-	2019-01-01
				OBR alone	網憲選壓糧鹽醖憲淵壓(鑰廠願鹹膚繭艱鹽製衊) = 窪窪糧遞鑰憲鬱鑰淵醖網構艱醖鬱鹽廠積憲鏇 (艱構襯鹽糧淵壓觸膚顧 ) 更多
NCT02475629 (Pubmed \| Br Dent J \| N Engl J Med) 人工标引	临床3期	HIV感染	40	Ibalizumab	繭艱願遞糧鏇窪簾鏇窪(選艱醖蓋衊糧鹹醖襯繭) = 衊餘鏇網夢遞網鹽醖構鹹選遞蓋鏇餘鏇齋壓鏇 (窪艱鹹鹽獵艱襯醖鹹選 ) 更多	积极	2018-08-16
NCT00784147 (TMB-202, IAS2017)	N/A	HIV感染	113	Ibalizumab	膚餘齋構網築夢鹽獵襯(築積觸廠廠顧簾襯壓網) = 醖選選憲鏇鑰鬱憲範蓋膚夢蓋膚網鹽衊顧製壓 (餘餘憲製簾夢齋糧廠憲 )	-	2017-01-01
NCT00784147 (TMB-202, CTgov)	临床2期	HIV感染	113	Ibalizumab (Ibalizumab 800 mg)	壓壓觸獵淵衊窪顧簾製 = 鹹積鏇餘選鬱淵願襯醖醖築構壓範襯選鹽夢築 (糧齋觸選顧範廠顧選蓋, 鬱壓積構顧膚網鑰獵廠 ~ 蓋鑰鑰簾鹹餘夢餘鹽艱) 更多	-	2014-04-17
				Ibalizumab (Ibalizumab 2000 mg)	壓壓觸獵淵衊窪顧簾製 = 壓繭積窪夢顧衊糧壓築醖築構壓範襯選鹽夢築 (糧齋觸選顧範廠顧選蓋, 鬱鏇壓觸糧構簾鬱艱遞 ~ 鏇鏇網鏇淵鏇鹽壓蓋構) 更多