A Clinical Study Evaluating the Safety, Tolerability, and Effect on HIV Reservoir of Ibalizumab Combined With Chidamide (a Histone Deacetylase Inhibitor) in People Living With HIV

HIV viral reservoirs represent the major barrier to curing AIDS, and effectively reducing viral reservoirs in people living with HIV through different strategies has become a research priority in the HIV field.
Ipilimumab-tovorafenib monoclonal antibody injection (Aituo combination antibody, QL1706) contains two engineered monoclonal antibodies targeting PD-1 and CTLA-4. Chidamide is the first independently developed histone deacetylase inhibitor in China. This study aims to evaluate the safety and efficacy of Aituo combination antibody combined with chidamide in people living with HIV.
This study adopts a modified "1+3+3" dose-escalation design. Initially, one participant will be enrolled at dose level 1 (DL1) for safety observation. If the treatment is well tolerated, the study will proceed to a standard 3+3 design, with sequential dose escalation to DL2 and DL3.
Three dose levels are planned: DL1, the starting dose, consists of ipilimumab-tovorafenib monoclonal antibody injection at 0.3 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL2 consists of ipilimumab-tovorafenib monoclonal antibody injection at 1 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks. DL3 consists of ipilimumab-tovorafenib monoclonal antibody injection at 2 mg/kg once every 4 weeks ± 1 day for a total of three doses, in combination with chidamide 10 mg orally twice weekly for 12 weeks.
During dose escalation, progression to the next dose level or discontinuation of escalation will be determined according to the occurrence of dose-limiting toxicities (DLTs). The DLT observation window is 28 days after the first dose. Participants evaluable for DLT are those who complete the observation window or experience a DLT. After completion of dose escalation, the maximum tolerated dose (MTD) will be determined based on safety and tolerability. If the MTD is not reached, DL3 will be selected as the dose for subsequent study.
After determination of the MTD or the subsequent study dose, an additional 11 participants will be enrolled at that dose level to further evaluate safety, tolerability, and preliminary efficacy. The maximum total sample size of the study will be 29 participants.

Start Date01 Jun 2026

Sponsor / Collaborator

The First Affiliated Hospital, Zhejiang University Sch of Med

NCT05495204

/ CompletedNot Applicable

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.

Start Date05 Aug 2022

Sponsor / Collaborator

Epividian, Inc.

[+1]

NCT05388474

/ CompletedNot Applicable

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.

Start Date22 Mar 2022

Sponsor / Collaborator

Theratechnologies, Inc.

[+2]

100 Clinical Results associated with Ibalizumab-UIYK

100 Translational Medicine associated with Ibalizumab-UIYK

100 Patents (Medical) associated with Ibalizumab-UIYK

Literatures (Medical) associated with Ibalizumab-UIYK

01 Aug 2026·AIDS PATIENT CARE AND STDS

People with HIV Continuing on Complex Regimens in the Era of Treatment Optimization: Characteristics and Outcomes

Article

Author: Sax, Paul E. ; McEwen, Isobel ; Eron, Joseph J. ; Benson, Paul ; Park, Seojin ; Ruhs, Sebastian ; Santiago, Steven ; Radtchenko, Janna ; Walworth, Charles ; Gandhi-Patel, Bhumi ; Dunn, Keith J. ; Ramgopal, Moti ; Mounzer, Karam ; Elion, Richard A.

While once-daily single-tablet regimens (STRs) are recommended for most people with human immunodeficiency virus (HIV; PWH), some require complex antiretroviral (ARV) regimens due to resistance, contraindications, or drug–drug interactions. We characterized PWH who were virologically suppressed on complex regimens (VS on CR) in a U.S. cohort to inform treatment optimization as new switch options emerge. This retrospective study analyzed electronic medical records from the Trio Health HIV Network and genotypic resistance data from Labcorp. We included PWH ≥ 18 years who were virologically suppressed (viral load [VL] < 200 copies/mL) at complex regimen initiation between January 2016 and November 2023, with ≥6 months from last prescription and ≥1 year of follow-up. Complex regimens included ≥2 of 3 core ARV classes concomitantly, more than once-daily dosing, multi-tablet regimens (MTRs) not replaceable by STRs, or resistance to two ARV classes. Virologic failure (VF) was defined as VL ≥ 500 copies/mL or two consecutive VLs ≥ 200 copies/mL. PWH on ibalizumab, fostemsavir, or lenacapavir were excluded to reflect standard clinical practice. Of 43,236 PWH with ARV prescriptions, 3,320 (8%) were VS on CR. Among these, 69% were on MTRs, 43% used ≥2 core ARV classes, and 11% had resistance to two classes. The median age was 52 years, and 77% were male. Common comorbidities included obesity (69%), neuropsychiatric disorders (35%), and cardiovascular disease (33%). Regimens predominantly included protease inhibitors (77%), nucleoside reverse transcriptase inhibitors (75%), and integrase strand transfer inhibitors (57%). Over a median 2.2-year follow-up, 4% experienced VF. Approximately 8% of PWH on ART remain VS on CR, underscoring the need for education on regimen optimization and novel treatment options for those unable to simplify their therapy.

01 Apr 2026·JOURNAL OF MEDICAL VIROLOGY

HIV‐1 Non Group‐M Phenotypic Susceptibility to Ibalizumab

Article

Author: Jullien, Henri ; Poisson, Lucie ; Plantier, Jean‐Christophe ; Alessandri‐Gradt, Elodie ; Lermechain, Fanny ; Hingrat, Quentin Le ; Tombette, Fabienne

ABSTRACT:

The study assessed the phenotypic susceptibility of non group‐M human immunodeficiency virus type 1 (HIV‐1/non‐M) clinical isolates to ibalizumab, the first‐in‐class long‐acting CD4‐directed post‐attachment inhibitor. Thirty isolates were tested: 1 HIV‐1/M (reference strain BRU.HXB2), 2 HIV‐1/N, 26 HIV‐1/O and 1 HIV‐1/P. A phenotypic in vitro assay was performed by pre‐incubating peripheral blood mononuclear cells with ibalizumab, (1–10 000 ng/mL), then infected and incubated before quantifying viral load with RT‐PCR. IC 50 , maximum percent inhibition (MPI), and fold change (FC) were calculated. Potential N ‐glycosylation sites (PNGS) in the V5 loop, V2 loop length and the side chain at position 375 were investigated. Ibalizumab inhibited 22 HIV‐1/O and 1 HIV‐1/N strains, with a median IC 50 of 0.0413 (range: 6.19E10 −11 ; 16.8) ng/mL and a median MPI of 96.9 (range: 68.4; 99.3)%. The HIV‐1/P strain displayed potential resistance (IC 50 > 10 000 ng/mL; MPI < 25%). Interpretable results were not obtained for 4 HIV‐1/O and 1 HIV‐1/N strains under standardization criteria. PNGS numbers in the V5 loop ranged from 0 to 4 in tested isolates. Ibalizumab showed in vitro activity against all validated HIV‐1/O and HIV‐1/N isolates, whereas the HIV‐1/P strain exhibited potential natural resistance. No relationship was observed between PNGS number and susceptibility.

17 Mar 2026·CLINICAL INFECTIOUS DISEASES

Combined Use of Ibalizumab and Lenacapavir for the Treatment of Multidrug-resistant HIV-1: A Case Series

Article

Author: Finkel, Diana ; Achhra, Amit ; Rolle, Charlotte ; Lucasti, Christopher ; McClendon, Tammie ; Martorell, Claudia ; Harbison, Christina ; Slim, Jihad

Abstract:

Background:

Some individuals with human immunodeficiency virus (HIV-1) have acquired multidrug-resistant (MDR) strains of HIV and/or are nonadherent to antiretroviral (ARV) medication. Injectable ARVs can provide salvage therapy for those with limited therapeutic options and may be preferred by some people with HIV (PWH). Real-world evidence may contribute to a more comprehensive understanding of the barriers to adherence and the utility of injectable ARVs in PWH. Currently, there is a lack of data on combined use of injectable ibalizumab (IBA) and lenacapavir (LEN) with optimized background regimen (OBR).

Methods:

A retrospective observational study examined medical charts from people with MDR HIV across 8 facilities in the United States. All PWH used a combination of both IBA + LEN ± OBR for at least 6 months. Viral loads and CD4+ counts were collected.

Results:

A total of 21 PWH were included. Four-class resistance at baseline was reported in 38.1% of PWH. Within 12 to 24 weeks of combined IBA + LEN treatment, a median reduction of −2710 copies/mL HIV RNA was observed. Median increase to CD4+ count was 67.5 cells/mm3 within 4 to 44 weeks of treatment initiation. Few intolerances required changes to treatment. Therapy with IBA + LEN continued for an average of 30 months and 20 months, respectively.

Conclusions:

In this small group of individuals with MDR HIV who were heavily treatment-experienced and/or faced adherence challenges, the use of IBA + LEN ± OBR was well tolerated and led to clinically significant reductions in viral loads and improvements in CD4+ counts.

News (Medical) associated with Ibalizumab-UIYK

15 Jul 2026

·www.biospace.com

TaiMed Biologics (4147) Receives TFDA Drug License Collection Notice for Trogarzo, Marking the Final Step Toward Commercial Launch in Taiwan

TAIPEI, July 07, 2026 (GLOBE NEWSWIRE) -- TaiMed Biologics (TPEX: 4147) announced today that its HIV therapy Trogarzo (ibalizumab; English name: Trogarzo Injection; Chinese name: 佐加洛注射劑) has officially received a Drug License Collection Notice from the Taiwan Food and Drug Administration (TFDA). Its commercialization partner, Orient EuroPharma Co., Ltd. ("Orient EuroPharma"; TPEX: 4120), will complete the required procedures to obtain the drug license in accordance with TFDA regulations, marking the final step toward the commercial launch of Trogarzo in Taiwan. TaiMed stated that Trogarzo received a TFDA Approval Letter in June this year, formally approving its English and Chinese product names and therapeutic indication. Receipt of the TFDA Drug License Collection Notice signifies that the regulatory review process has been completed. Upon completion of the drug license issuance procedures and other commercialization preparations by Orient EuroPharma, Trogarzo will be officially launched in Taiwan, providing a new treatment option for patients living with multidrug-resistant HIV-1 infection. Trogarzo (ibalizumab) is the world's first and currently the only CD4-directed monoclonal antibody approved for the treatment of HIV. It is indicated, in combination with other antiretroviral agents, for the treatment of adults with multidrug-resistant HIV-1 infection who are heavily treatment-experienced and whose current antiretroviral regimen is failing. Trogarzo has received approval from the U.S. Food and Drug Administration (FDA) in both intravenous infusion (IV infusion) and intravenous push (IV Push) formulations. TaiMed is also actively pursuing regulatory approvals in additional countries and regions to further expand its global commercial footprint. TaiMed noted that it entered into an exclusive commercialization and distribution agreement with Orient EuroPharma for the Taiwan market in May 2024. Under the agreement, TaiMed is responsible for product supply, while Orient EuroPharma is responsible for regulatory registration, marketing, and commercialization. With its extensive experience in infectious disease and specialty pharmaceuticals, together with its well-established hospital network, Orient EuroPharma is well positioned to accelerate Trogarzo's market introduction in Taiwan and improve patient access to this innovative therapy. TaiMed further noted that although Trogarzo primarily addresses the relatively small salvage-treatment market for patients with multidrug-resistant HIV, the product offers a highly differentiated clinical pro has established a solid commercial foundation, continuing to contribute stable revenue to the Company. In the first quarter of this year, TaiMed successfully achieved profitability, marking a return to positive earnings and demonstrating the success of its Trogarzo commercialization strategy and global market expansion. Beyond Trogarzo, TaiMed is actively advancing the global clinical development of its next-generation long-acting dual broadly neutralizing antibody (bNAb) HIV therapy, TMB-365/380. The program completed Last Patient In (LPI) for its Phase 2b clinical trial in May 2026 and is expected to reach its interim data readout by the end of this year. Designed for once-every-two-month (Q2M) dosing, TMB-365/380 has the potential to become the world's first long-acting HIV antibody regimen that does not require viral susceptibility screening prior to treatment initiation, targeting the substantially larger first-line HIV maintenance therapy market. Peak annual global sales are estimated to reach US$3–4 billion. Subject to favorable clinical results and regulatory progress, the Company plans to pursue Breakthrough Therapy Designation (BTD) with the U.S. FDA, while advancing global licensing partnerships and commercialization opportunities. Dr. Jimmy Chang, CEO of TaiMed Biologics, commented: "Receiving the TFDA Drug License Collection Notice for Trogarzo represents another important validation of our years of research and development efforts and reflects the successful execution of our three core strategies—innovation, manufacturing, and commercialization. Looking ahead, we will continue expanding our global HIV portfolio by accelerating Trogarzo's international commercialization and advancing the global development of TMB-365/380. Our goal is to become a global leader in innovative HIV therapies while delivering sustainable long-term growth and value to our shareholders." 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 is advancing TMB-365/380, its lead clinical-stage long-acting maintenance therapy candidate for people living with HIV. 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. Forward-Looking Statements This press release contains forward-looking statements, including projections regarding clinical timelines, regulatory submissions, commercial potential, and partnering discussions for TMB-365/380. These statements involve known and unknown risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, regulatory decisions, competitive dynamics, and market conditions. TaiMed Biologics undertakes no obligation to update forward-looking statements except as required by applicable law. Contacts Investor Relations/Media Kenny Lin hlin@taimedbio.com

Drug ApprovalPhase 2NDABreakthrough Therapy

22 May 2026

·www.biospace.com

TaiMed Biologics Completes Phase 2b Enrollment for TMB-365/380 in HIV Maintenance Therapy Study

Last Patient In enrolled ahead of schedule; interim analysis anticipated by year-end 2026 to inform plans for the next stage of development TAIPEI, May 21, 2026 (GLOBE NEWSWIRE) -- TaiMed Biologics (TPEX: 4147) today announced the completion of enrollment in its Phase 2b clinical study evaluating TMB-365/380, a novel investigational long-acting dual-antibody regimen for HIV maintenance therapy. The study reached Last Patient In (LPI) ahead of the planned schedule, marking an important operational milestone for the program. The Phase 2b study is designed to evaluate the efficacy and safety of TMB-365/380 as an every-two-month (Q2M), first-line HIV maintenance therapy for people living with HIV. With enrollment now complete, participants will continue scheduled follow-up, and TaiMed expects to report an interim analysis by year-end 2026. The Company believes the interim readout may help inform subsequent development and regulatory planning. Preliminary observations from ongoing follow-up show that viral suppression and relevant biomarkers following the first two doses are fully consistent with the Company’s expectations. Subject to continued positive outcomes, the Company plans to submit a Breakthrough Therapy Designation (BTD) application to the U.S. Food and Drug Administration (FDA). “Completing enrollment ahead of schedule reflects the strong execution of our clinical team and the commitment of our investigators, study sites, and participants,” said Dr. Jimmy Chang, Chief Executive Officer of TaiMed Biologics. “The accelerated enrollment highlights strong engagement from clinical sites and interest in Q2M long-acting treatment approaches. We believe TMB-365/380 has the potential to be the first long-acting bNAb combination to demonstrate high rates of viral suppression without the need for susceptibility screening, a distinction that could improve clinical access and patient convenience. We look forward to reporting interim data later this year.” TaiMed estimates peak annual global sales of TMB-365/380 at approximately USD $3–4 billion. TMB-365/380’s potential to offer a long-acting, infrequent-dosing treatment option without the need for susceptibility screening may support broad clinical use and differentiation within the evolving HIV treatment landscape. TaiMed Biologics is exploring potential strategic partnerships, including licensing and co-development opportunities, to support the global development and commercialization of TMB-365/380. 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 is advancing TMB-365/380, its lead clinical-stage long-acting maintenance therapy candidate for people living with HIV. 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. Forward-Looking Statements This press release contains forward-looking statements, including projections regarding clinical timelines, regulatory submissions, commercial potential, and partnering discussions for TMB-365/380. These statements involve known and unknown risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, regulatory decisions, competitive dynamics, and market conditions. TaiMed Biologics undertakes no obligation to update forward-looking statements except as required by applicable law. Contacts Investor Relations Jonathan Ho jho@taimedbio.com Media Sofia Bermudez LifeSci Communications sbermudez@lifescicomms.com

Phase 2Drug ApprovalBreakthrough Therapy

11 Sep 2025

·www.globenewswire.com

Nancy T. Chang, Proven Biotechnology Leader, Joins Immix Biopharma Board of Directors

– Dr. Chang led XOLAIR® from invention through FDA approval and commercialization, exceeding $5 billion in sales so far – Los Angeles, CA, Sept. 11, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Company”, “We” or “Us”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Nancy T. Chang, former Tanox, Inc. CEO and proven biotechnology leader, has joined the Immix Biopharma Board of Directors concurrent with her investment as founding member of Goose Capital. At Tanox, Dr. Chang and her team invented and developed FDA-approved XOLAIR® (omalizumab) for severe asthma, TROGARZO® (ibalizumab-uiyk) for HIV, and EBGLYSS® (lebrikizumab-lbkz) for dermatitis, collectively generating drug sales exceeding 5 billion dollars so far. Tanox, Inc. was acquired by Genentech/Roche for $919 million. EBGLYSS® is commercialized by Eli Lilly and Co. About Immix Biopharma, Inc.Immix Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201 with a “digital filter” that filters out non-specific activation. NXC-201 is being evaluated in the U.S. multi-center study for relapsed/refractory AL Amyloidosis NEXICART-2 (NCT06097832), with a registrational design. NEXICART-2 primary endpoint was met at interim results presented at ASCO 2025. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at www.immixbio.com and www.BeProactiveInAL.com. Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as “expects”, “contemplates”, “anticipates”, “plans”, “intends”, “believes”, “estimates”, “potential”, and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section “Risk Factors” included in the Company’s Annual Report on Form 10-K filed with the SEC on March 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at www.sec.gov. Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. ContactsMike MoyerLifeSci Advisorsmmoyer@lifesciadvisors.com Company Contactirteam@immixbio.com

Cell TherapyOrphan DrugDrug ApprovalImmunotherapyClinical Study

100 Deals associated with Ibalizumab-UIYK

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KEGG	Wiki	ATC	Drug Bank
D09575	Ibalizumab-UIYK	J05AX23	DB12698

R&D Status

Approved

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Theratechnologies, Inc.	06 Mar 2018

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Acquired Immunodeficiency Syndrome	Phase 3	United States	TaiMed Biologics, Inc.	01 Aug 2015
Acquired Immunodeficiency Syndrome	Phase 3	Taiwan Province	TaiMed Biologics, Inc.	01 Aug 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03913195 (CTgov)	Phase 3	HIV Infections	43	ibalizumab-uiyk (Core Group-HIV Uninfected)	guhhcnhmmm = shbyfgqcxt ijfblkwlxl (synzvcdxzz, dhqiptxffp - hdjboybjhv) View more	-	20 Oct 2025
				ibalizumab-uiyk (Intramuscular Injection Group-HIV+)	oplrbvnpqw = mxmxrvusxb natrgvnheo (tsupmoiuut, ysyvodyxim - dgbsooybjj) View more
NCT05388474 (PROMISE-US, Company_Website) Manual	Phase 4	HIV Infections	112	matched patients not receiving ibalizumab (Cohort 1)	cvczxwdnbe(gqilzswcaz) = 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). hmwkxcxqmk (pmxcuabwjg ) View more	Positive	12 Mar 2025
				ibalizumab (Cohort 2)
Biospace Manual	Phase 2/3	HIV Infections	76	ibalizumab 800 mg	ljtvqzyeri(oprdgwyctv): 1.98 (95% CI, 1.02 - 3.69) View more	Positive	12 Jul 2023
				non-ibalizumab-containing regimens
NCT00089700 (Pubmed \| J Acquir Immune Defic Syndr)	Phase 2	HIV Infections	82	Ibalizumab 15 mg/kg q2wk	dwefhexxcf(tinzquqeml) = No ibalizumab-related serious adverse events were reported sibffhoalu (cuyrtelwzg )	Positive	01 Apr 2021
				Ibalizumab 10 mg/kg weekly for 9 weeks, then q2wk
NCT02707861 (CTgov)	Phase 3	HIV Infections	79	Optimized Background Regimen+ibalizumab (Cohort 1)	kgypubumly = fophtxifih ionvpncodh (ewhdxdxcho, lvpbeuapej - ytftsjbnpl) View more	-	11 Mar 2021
				Optimized Background Regimen+ibalizumab (Cohort 2)	kgypubumly = ksrkxiqzvg ionvpncodh (ewhdxdxcho, mkrxpgofqz - fzdahvonzm) View more
NCT02475629 (CTgov)	Phase 3	Acquired Immunodeficiency Syndrome \| HIV Infections	40	Optimized Background Regimen (OBR)+ibalizumab	ykybyulist = gitpuuquze dxfokinuox (kwjqxrpjie, cxiqwafbop - fezpcpydhl) View more	-	19 Mar 2020
NCT02475629 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	HIV Infections	40	Ibalizumab	vtthiteduy(bbrtlbdtam) = lqnmgjaowu qmiyoeynqe (ceawpuoejv ) View more	Positive	16 Aug 2018
NCT00784147 (TMB-202, IAS2017)	Not Applicable	HIV Infections	113	Ibalizumab	exttxfnhjo(rfpjobciql) = cncbtjgonv duefwnjxbk (rstjaurexh )	-	01 Jan 2017
NCT00784147 (TMB-202, CTgov)	Phase 2	Acquired Immunodeficiency Syndrome \| HIV Infections	113	Ibalizumab (Ibalizumab 800 mg)	fjsnimtmap = ptnmibnftc jdtsmhjryx (zvdzcdylet, vuowoofxhi - ozfxahbfcm) View more	-	17 Apr 2014
				Ibalizumab (Ibalizumab 2000 mg)	fjsnimtmap = ouookssfbw jdtsmhjryx (zvdzcdylet, hllqpnzkha - iqtyggiuwq) View more
IAS2006	Not Applicable	-	82	TNX-355 15mg/kg+OBR	okcempjsvz(tsprlgdciu) = oyybmxqimi whdosovcyn (yjaqjxusih )	-	01 Jan 2006
				TNX-355 10mg/kg+OBR	okcempjsvz(tsprlgdciu) = dipnrnbxbi whdosovcyn (yjaqjxusih )

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