The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.

Start Date01 Jul 2025

Sponsor / Collaborator

University of Miami

[+1]

CTR20232029

/ CompletedNot Applicable

一项随机、开放、两序列交叉设计，评价健康成人空腹/餐后状态下单次口服硫酸阿巴卡韦片的生物等效性试验

[Translation] A randomized, open-label, two-sequence crossover design study to evaluate the bioequivalence of abacavir sulfate tablets in healthy adults with a single oral dose in the fasting/fed state

主要目的：考察中国健康受试者在空腹/餐后条件下单剂量口服上海迪赛诺医药集团股份有限公司生产的硫酸阿巴卡韦片（规格：300mg）与ViiV Healthcare B.V.持证、 GlaxoSmithKline Pharmaceuticals SA生产的硫酸阿巴卡韦片（商品名：赛进®/ZIAGEN®，规格：300mg）后的体内药代动力学特征，评价两制剂的生物等效性。次要目的：评价单剂量口服硫酸阿巴卡韦片受试制剂（规格：300mg）及参比制剂（商品名：赛进®/ZIAGEN®，规格：300mg）在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of abacavir sulfate tablets (specification: 300 mg) produced by Shanghai Desano Pharmaceutical Group Co., Ltd. and abacavir sulfate tablets (trade name: ZIAGEN®/ZIAGEN®, specification: 300 mg) produced by ViiV Healthcare B.V. and GlaxoSmithKline Pharmaceuticals SA in healthy Chinese subjects after single oral administration under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation (specification: 300 mg) and the reference preparation (trade name: ZIAGEN®/ZIAGEN®, specification: 300 mg) of abacavir sulfate tablets in healthy Chinese subjects after single oral administration.

Start Date02 Jul 2023

Sponsor / Collaborator

Shanghai Desino Biopharmaceutical Co., Ltd.

NCT04731103

/ CompletedPhase 2IIT

Inhibition of Reverse Transcription in Type I Interferon Mediated Neuropathology

Aicardi-Goutières syndrome (AGS) is a disease of children, particularly affecting the brain and the skin. There is a close link between AGS and increased amounts of a chemical called interferon. Normally humans only produce interferon when they are infected with a virus. In AGS, there is no viral infection. Instead, the cells in the cells of affected patients are confused into thinking that their own genetic material is coming from a virus. As a result they produce interferon all the time, which acts as a poison that damages the cells. The Investigators wish to treat AGS patients with drugs called reverse transcriptase inhibitors (RTIs), used to fight the HIV-1 virus that causes AIDS. The investigators will monitor the effect of treatment on interferon levels, and look at other markers which might give us clues to how the drugs are working. The trial is funded by the Medical Research Council, and involves experts based in Edinburgh, Birmingham, Manchester and Great Ormond Street Hospital.

Start Date24 Aug 2022

Sponsor / Collaborator

The University of Edinburgh

[+2]

100 Clinical Results associated with Abacavir Sulfate

100 Translational Medicine associated with Abacavir Sulfate

100 Patents (Medical) associated with Abacavir Sulfate

4,409

Literatures (Medical) associated with Abacavir Sulfate

01 May 2025·BIOMATERIALS

Gene-engineered polypeptide hydrogels with on-demand oxygenation and ECM-cell interaction mimicry for diabetic wound healing

Article

Author: Fan, Jin-Xuan ; Gao, Cheng-Hao ; Tan, Lin-Fang ; Chen, Liang-Xi ; Xie, Xiao-Ting ; Liu, Bo ; Zhao, Yuan-Di ; Xiong, Wei ; Cheng, Kai

The treatment of infected diabetic wounds remains a significant clinical challenge due to pathogen infection, excessive inflammation, and impaired angiogenesis with troubled extracellular matrix (ECM) - cell and cell - cell interaction. Herein, we prepared a Janus polypeptide-engineered hydrogel with programmable function driven by self-assembly of the same A domain. The hydrogel was composed of a V8-degradable AC₁₀A layer loaded with hybrid phages (ABC) for precise bacterial inhibition and a PC₁₀ARGD layer loaded with Mn-based mineralized erythrocyte (PEM) for continuous supply oxygen on demand. The results of laser speckle contrast imaging, photoacoustic imaging, and hyperspectral imaging demonstrated that the AC₁₀A@BP-Ce6/PC₁₀AR@EM hydrogel (ABC/PEM) accelerated the reconstruction of normal skin structure by breaking the oxygen diffusion barrier and supplying oxygen on demand to promote angiogenesis and functionalization. In addition, in vitro and in vivo experiment results showed that the ABC/PEM hydrogel can mimic positive ECM - cell interaction to inhibit the polarization of macrophage towards M1-type to slow down the inflammatory process by down-regulated yes-associated protein (YAP), and relieve the mechanical tension of fibroblasts and keratinocytes. Finally, the ABC/PEM hydrogel promotes a healing rate of 98.83 % on day 21 and results in the number of dermal appendages being eight times that of the negative group. This work presents an effective strategy for diabetes-related chronic infected wound management.

01 Mar 2025·COMPLEMENTARY THERAPIES IN MEDICINE

Impact of cooling diabetic patients’ fingertips compared to vibrating stimulation on pain from the glucometer needle: A cross-over trial study

Article

Author: Tapak, Leili ; Oshvandi, Khodayar ; Vejdanihemmat, Vahid ; Borzouei, Shiva ; Azami, Hiva

INTRODUCTION:

Blood glucose measurements using glucometers can cause discomfort due to needle insertion. Implementing effective pain management strategies is essential to alleviate this discomfort. This study aimed to evaluate the effects of cold and vibration stimulation on pain perception during glucometer needle insertion in diabetic patients.

METHODS:

Sixty diabetic inpatients from Shahid Beheshti Hospital in Hamadan, Iran, participated in a crossover study, comprising 3 individuals with type 1 diabetes and 57 with type 2 diabetes. The cohort included 40 males and 20 females, with ages ranging from 18 to 70 years and a mean age of 55.7 years. The average duration of diabetes was 10 years. The study design consisted of six blocks, each containing three interventions: vibration stimulation (A), cold therapy (B), and a combination of both C. The sequences of interventions (ABC, ACB, BCA, BAC, CBA, and CAB) were randomly assigned. Each participant received the interventions at three different times: before breakfast, one to two hours after lunch, and at dinner. One hand was randomly selected for the intervention, while the other served as a control, with only the needle inserted. Pain levels were assessed using the Numeric Rating Scale (NRS) for both hands.

RESULTS:

Participants receiving vibration stimulation in one hand reported a significant reduction in pain intensity, with a mean difference of 1.21 (p < 0.001) compared to the control hand. In contrast, cold therapy did not significantly affect pain intensity, showing a mean difference of only 0.06 (p > 0.05). The combination of vibration and cold therapy also did not significantly alter pain intensity, yielding a mean difference of 0.33 (p > 0.05). A significant difference (p = 0.002) was noted among the interventions, indicating varying effects on pain intensity.

CONCLUSION:

Vibration stimulation effectively reduces pain associated with glucometer needle insertions. Among the methods examined, vibration stimulation proved to be the most effective for minimizing needle pain. Clinicians are encouraged to incorporate this technique into the care of diabetic patients to enhance their comfort during glucose monitoring.

21 Feb 2025·MEDICINE

Efficacy and safety of switch to bictegravir/emtricitabine/tenofovir alafenamide from dolutegravir/abacavir/lamivudine: Results from an open-label extension of a phase 3 randomized, double-blind, multicenter, active-controlled, non-inferiority study

Article

Author: Benson, Paul ; Ramgopal, Moti ; Ruane, Peter J. ; Brar, Indira ; Henry, Keith ; Berhe, Mezgebe ; Liu, Hui ; Brinson, Cynthia ; Hindman, Jason T. ; Andreatta, Kristen

Background::

The phase 3 randomized, active-controlled GS-US-380-1844 (NCT02603120) study evaluated switching to the single-tablet regimen bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG), abacavir (ABC), and lamivudine (3TC) among people with HIV-1. Previously, results from the 48-week double-blind phase showed that switching to B/F/TAF was noninferior to remaining on DTG/ABC/3TC and that B/F/TAF was well tolerated. Here, we show the long-term safety and efficacy of switching to B/F/TAF from DTG/ABC/3TC among people with HIV-1.

Methods::

Participants were virologically suppressed people with HIV-1 (HIV-1 RNA <50 copies/mL for ≥ 3 months prior to screening) receiving DTG/ABC/3TC at baseline. Participants were randomized 1:1 to switch to B/F/TAF or remain on DTG/ABC/3TC. Following 48 weeks of treatment with B/F/TAF or DTG/ABC/3TC in the double-blind phase, participants had the option to enter an open-label extension phase, during which they received B/F/TAF. Virologic, immunologic, and safety outcomes during treatment with B/F/TAF through the open-label extension up to 168 weeks, including preexisting and treatment-emergent resistance, were analyzed.

Results::

Among 547 participants in the all-B/F/TAF analysis set, virologic suppression (HIV-1 RNA < 50 copies/mL) was maintained in 99% to 100% of participants up to 168 weeks into B/F/TAF treatment, including in those with preexisting resistance; no treatment-emergent resistance was detected. CD4 cell counts remained stable during B/F/TAF treatment, with median (interquartile range) changes from baseline of −17 (−120, 65) cells/µL at week 48 and −9 (−100, 108) cells/µL at week 96. Safety and tolerability findings were consistent with previously reported findings up to week 48; most drug-related adverse events were grade 1 or 2 in severity; no new safety signals were identified.

Conclusion::

Switching to B/F/TAF from DTG/ABC/3TC was associated with continued high rates of virologic suppression up to week 168, with no treatment-emergent resistance. B/F/TAF was well tolerated throughout the study period.

News (Medical) associated with Abacavir Sulfate

26 Feb 2025

·investors.alector.com

Alector Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update

Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in FTD-GRN expected by Q4 2025 Anticipate completing enrollment in the PROGRESS-AD Phase 2 clinical trial of AL101/GSK4527226 in participants with early Alzheimer’s disease by mid-2025 Applying Alector Brain Carrier to advance therapeutic candidates, including those targeting amyloid beta and replacing GCase $413.4 million in cash, cash equivalents and investments provide runway through 2026 Management to host conference call and webcast today at 4:30 p.m. ET/1:30 p.m. PT SOUTH SAN FRANCISCO, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegeneration, today reported fourth quarter and full year 2024 financial results and recent portfolio and business updates. As of December 31, 2024, Alector’s cash, cash equivalents and investments totaled $413.4 million. “Alector is entering a potentially transformative period for the company, as we continue to advance our clinical programs toward key milestones while also driving the development of our wholly owned, early-stage pipeline,” said Arnon Rosenthal, Ph.D., Chief Executive Officer of Alector. “We look forward to reporting topline data from the pivotal INFRONT-3 Phase 3 trial of latozinemab targeting frontotemporal dementia with a granulin gene mutation by the fourth quarter. Additionally, we expect to complete enrollment in the PROGRESS-AD Phase 2 trial of AL101/GSK4527226 in participants with early Alzheimer’s disease by mid-2025. With our broad and diverse portfolio of genetically validated drug candidates for the treatment of neurodegenerative diseases, backed by a strong financial position that will fund operations through 2026, Alector is well-positioned to advance our mission to deliver transformative therapies for patients with neurodegenerative brain disorders.” Sara Kenkare-Mitra, Ph.D., President and Head of Research and Development at Alector, added, “We are making significant progress in advancing Alector’s preclinical and research pipeline. By leveraging our expertise in neuroscience and drug discovery, and selectively applying our proprietary Alector Brain Carrier technology platform, we are able to enhance brain delivery and biodistribution of therapeutic cargo to potentially improve safety and efficacy. We are currently selecting lead candidates for two programs, ADP037-ABC, targeting amyloid beta, and ADP050-ABC, replacing GCase. We aim to advance these programs toward IND-enabling studies later this year, with plans to enter the clinic in 2026.” Recent Clinical Updates Progranulin Programs (latozinemab (AL001) and AL101/GSK4527226) Being Developed in Collaboration with GSK Latozinemab The pivotal, randomized, double-blind, placebo-controlled INFRONT-3 Phase 3 clinical trial of latozinemab targeting frontotemporal dementia with a granulin gene mutation (FTD-GRN) is ongoing. Topline data are anticipated by the fourth quarter of 2025. Latozinemab is a novel investigational human monoclonal antibody (mAb) designed to block and downregulate the sortilin receptor to elevate the level of progranulin (PGRN) in the brain. It has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations, and the company believes it is the most advanced PGRN-elevating candidate in development for this condition. AL101/GSK4527226 PROGRESS-AD, a global, randomized, double-blind, placebo-controlled Phase 2 clinical trial evaluating AL101/GSK4527226 in early Alzheimer’s disease (AD) continues to enroll well, with substantial progress toward its target enrollment of 282 participants. Alector and GSK plan to complete trial enrollment by mid-2025. AL101/GSK4527226 is an investigational human mAb designed to block and downregulate the sortilin receptor to elevate the level of PGRN in the brain in a manner that is similar to investigational latozinemab but with different pharmacokinetic and pharmacodynamic properties, making it suitable for the potential treatment of more prevalent neurodegenerative diseases. Preclinical and Research Pipeline Alector is advancing a preclinical and early research pipeline focused on removing toxic proteins, replacing deficient proteins, and restoring immune and nerve cell function. Leveraging its deep expertise in drug development and proprietary technologies, including protein engineering, antibody discovery, and its Alector Brain Carrier (ABC) platform for blood-brain barrier transport, the company is progressing a curated portfolio of programs targeting genetically validated disease mechanisms. This approach has led to a suite of innovative programs with the potential to make a significant impact on neurodegeneration. ADP037-ABC is a proprietary anti-amyloid beta (Aβ) antibody paired with the company’s ABC for the treatment of AD. It is designed to remove brain Aβ plaques, with the potential to reduce the incidence and/or severity of amyloid-related imaging abnormalities (ARIA) and enable subcutaneous delivery. It targets a validated epitope, specific to brain Aβ plaques, combined with an optimized antibody constant region to enhance phagocytosis of Aβ plaques. By leveraging ABC technology, ADP037-ABC aims to clear Aβ efficiently, thereby reducing plaque accumulation and potentially slowing disease progression while minimizing ARIA. ADP050-ABC is a GCase replacement therapy paired with the company’s proprietary ABC for GBA gene mutation carriers with Parkinson’s disease (PD) and Lewy body dementia. In these patients, mutations in the GBA gene lead to deficient GCase activity. ADP050-ABC uses Alector-engineered GCase, which is proprietary and has been designed to have a longer half-life and to break down glucocerebroside, a lipid that accumulates in neurons and contributes to neurodegeneration. This mechanism aims to reduce cellular dysfunction and slow disease progression. ADP056 is a Reelin modulator designed to block tau pathology and promote synaptic function in AD. Reelin, a large, secreted protein, regulates neuronal function and tau accumulation. Gain-of-function Reelin variants protect against familial AD through a mechanism that appears to uncouple amyloid and tau pathology. ADP056 is designed to mimic these protective effects of the Reelin mutation. ADP063-ABC and ADP064-ABC are therapeutic candidates paired with the company’s proprietary ABC that target tau pathology in AD through distinct approaches. First, ADP063-ABC will focus on combining a proprietary anti-tau antibody directed to a validated tau epitope with ABC and an optimized antibody constant region. It is designed to block the spread of tau aggregates and has the potential for subcutaneous delivery. Second, ADP064-ABC will focus on using an anti-tau siRNA combined with ABC, which aims to prevent the synthesis of the tau mRNA and protein. Both approaches seek to leverage a highly brain-penetrant approach to remove toxic tau and potentially slow cognitive decline in AD. In December 2024, Alector and co-recipient University of Luxembourg were awarded a $1.7 million grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) for collaborative research on glycoprotein nonmetastatic melanoma protein B (GPNMB), a PD target. Alector plans to hold an educational webinar in the second quarter of 2025 to present additional preclinical data on the company’s anti-amyloid beta and GCase programs, as well as advancements in ABC. TREM2 Program (AL002) On April 5, 2025, Alector plans to present the results from the INVOKE-2 Phase 2 clinical trial, which evaluated the safety and efficacy of AL002, a TREM2 agonist, in individuals with early AD, during an oral presentation at the AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s Diseases, taking place in Vienna, Austria. While the trial did not meet its primary endpoint, Alector remains committed to advancing the understanding of AD pathophysiology and the development of effective therapeutics for the disease. Fourth Quarter 2024 Financial Results Revenue. Collaboration revenue for the quarter ended December 31, 2024, was $54.2 million, compared to $15.2 million for the same period in 2023. Collaboration revenue for the year ended December 31, 2024, was $100.6 million, compared to $97.1 million for the same period in 2023. The increase in year-over-year collaborative revenue was primarily due to an increase in revenue recognized for the AL002 and latozinemab programs. Collaboration revenue under the AbbVie Agreement was fully recognized as of December 31, 2024. R&D Expenses. Total research and development expenses for the quarter ended December 31, 2024, were $46.5 million, compared to $47.7 million for the quarter ended December 31, 2023. Total research and development expenses for the year ended December 31, 2024, were $185.9 million compared to $192.1 million for the same period in 2023. The decrease in year-over-year R&D expenses was mainly due to the Company’s strategy to prioritize selected programs. G&A Expenses. Total general and administrative expenses for the quarter ended December 31, 2024, were $15.0 million compared to $14.9 million for the quarter ended December 31, 2023. Total general and administrative expenses for the year ended December 31, 2024, were $59.6 million compared to $56.7 million for the year ended December 31, 2023. The increase in year-over-year G&A expenses is primarily due to the impairment of the right-of-use asset and the leasehold improvements as the Company approved a plan to transition operations from our laboratory and offices in Newark, California to our South San Francisco Headquarters. Net Loss. For the quarter ended December 31, 2024, Alector reported a net loss of $2.1 million, or $0.02 net loss per share, compared to a net loss of $41.4 million, or $0.49 net loss per share, for the same period in 2023. For the year ended December 31, 2024, Alector reported a net loss of $119.0 million or $1.23 net loss per share, compared to a net loss of $130.4 million or $1.56 net loss per share, for the same period in 2023. Cash Position. Cash, cash equivalents, and investments were $413.4 million as of December 31, 2024. Management expects that this will be sufficient to fund current operations through 2026. 2025 Guidance. Management anticipates, for the year ending 2025, collaboration revenue to be between $5 million and $15 million, total research and development expenses to be between $175 million and $185 million, and total general and administrative expenses to be between $55 million and $65 million. Fourth Quarter and Full Year 2024 Conference Call Alector’s management team will host a conference call to discuss Alector’s results for the fourth quarter and full year 2024, as well as provide a business update. The conference call will be webcast and accessible via the investor relations section of Alector’s website at www.alector.com. To access the call, please use the following information: Date: Wednesday, February 26, 2025 Time: 4:30 p.m. ET, 1:30 p.m. PT The event will be webcast live under the investor relations section of Alector’s website at https://investors.alector.com/events-and-presentations/events and following the event a replay will be archived there for 30 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. About Alector Alector is a late-stage clinical biotechnology company focused on developing therapies to counteract the devastating progression of neurodegenerative diseases. Leveraging the principles of genetics, immunology and neuroscience, the company is advancing a portfolio of genetically validated programs that aim to remove toxic proteins, replace missing proteins, and restore immune and nerve cell function. Supported by biomarkers, Alector’s product candidates seek to treat a range of indications, including frontotemporal dementia, Alzheimer’s disease, Parkinson's disease, and Lewy body dementia. The company is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its next-generation product candidates and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper brain penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, business strategy, product candidates, blood-brain barrier technology platform, research and preclinical pipeline, planned and ongoing preclinical studies and clinical trials, anticipated timing of and detail regarding release of data for INFRONT-3, expected milestones, expectations of our collaborations, expectations of our interactions with regulatory authorities, and financial and cash guidance. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-K filed for 2024, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law. Alector Contacts: Alector Katie Hogan 202-549-0557 katie.hogan@alector.com Argot Partners (media) David Rosen (212) 600-1494 alector@argotpartners.com Argot Partners (investors) Laura Perry 212-600-1902 alector@argotpartners.com Source: Alector, Inc.

Phase 2Phase 3Financial StatementBreakthrough TherapyOrphan Drug

24 Jan 2025

·www.pharmaceutical-technology.com

FDA approves drug application for Lupin’s heart failure therapy

The approval covers dosages of the medicine comprising 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. Credit: Shidlovski/Shutterstock. The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin ’s Sacubitril and Valsartan tablets for heart failure patients. Sacubitril and Valsartan tablets are the generic equivalent of Novartis ‘ Entresto, used to reduce cardiovascular risks in adults with chronic heart failure and decreased ejection fraction. The approval covers dosages of 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg. They are also used for treating symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. The tablets are expected to tap into a market with annual US sales of $6.06bn. The company has also announced the receipt of tentative approval from the US regulator under the US President’s Emergency Plan for AIDS Relief (PEPFAR) for its Abacavir, Dolutegravir and Lamivudine tablets for oral suspension. This generic equivalent of ViiV Healthcare’s Triumeq PD tablets for oral suspension is set to be manufactured at the company’s Nagpur facility in India. The tablets are for distribution in low and middle-income nations. The Abacavir 60 mg/Dolutegravir 5 mg/Lamivudine 30 mg fixed-dose combo is intended for the treatment of human immunodeficiency virus (HIV)-1 infection in children aged three and above weighing at least 6kg, and is a once-a-day single-pill regimen. Lupin API Plus SBU head, global chief financial officer and executive director Ramesh Swaminathan stated: “We are committed to providing affordable and high-quality treatments for patients worldwide. The tentative approval from the US FDA for our Abacavir, Dolutegravir and Lamivudine tablets enables us to improve the well-being of paediatric patients with HIV-1, thereby significantly boosting our HIV medication portfolio.” In September 2024, the company entered a non-exclusive patent licence agreement with Takeda Pharmaceutical for the commercialisation of Vonoprazan tablets in India.

Drug ApprovalLicense out/in

08 Aug 2024

·www.drugs.com

Abacavir Use Linked to Increased Incidence of MACE

THURSDAY, Aug. 8, 2024 -- For patients with HIV in the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) trial, use of abacavir was associated with an increased incidence of major adverse cardiovascular events (MACE), according to a study presented at AIDS 2024, the 25th International AIDS Conference, held from July 22 to 26 in Munich. Carl J. Fichtenbaum, M.D., from the University of Cincinnati, and colleagues examined the role of prior and current use of antiretroviral agents (ART) on the development of MACE in a trial involving 7,769 participants aged 40 to 75 years on ART for at least 180 days. The median duration of ART use was 9.5 years, with variation by country. The researchers found that 22, 86, 49, and 47 percent of participants reported prior exposure to abacavir, tenofovir (TDF), thymidine analogs (AZT/d4T), and protease inhibitors (PIs), respectively. At study entry, 13, 61, 10, and 26 percent were using abacavir, TDF, AZT/d4T, and PIs, respectively. Entry regimens included two nucleoside reverse transcriptase inhibitors (NRTIs) plus a non-NRTI, integrase strand transfer inhibitor, or PI (47, 25, and 19 percent, respectively). Both former and current use of abacavir was associated with a higher incidence of MACE in adjusted analyses including the baseline regimen. No association was seen for former or current use of other ART agents with MACE. "Former and current use of abacavir was associated with a higher incidence of subsequent major adverse cardiovascular events in the REPRIEVE trial," the authors write. Press Release More Information Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical ResultAHAClinical Study

100 Deals associated with Abacavir Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D00891	Abacavir Sulfate	J05AF06	DB01048

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
HIV Infections	United States	ViiV Healthcare Co.	17 Dec 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
AIDS Dementia Complex	Phase 3	United States	Glaxo Wellcome SA	31 Aug 2001
AIDS Dementia Complex	Phase 3	Canada	Glaxo Wellcome SA	31 Aug 2001
Acidosis, Lactic	Phase 3	Canada	GSK Plc	01 Aug 2001
Hyperlactatemia	Phase 3	Canada	GSK Plc	01 Aug 2001
Hepatitis C	Phase 1	United States	GSK Plc	01 Dec 2009

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02384395 (PHI-05, CTgov)	Not Applicable	HIV Infections	40	Dolutegravir 50 mg+Abacavir 600 mg+Lamivudine 300 mg	cwyrsybcpq = uwrfbgudbm owbibcfxgp (zscprxseuo, xstirqnzrr - sektzsglbu) View more	-	22 Nov 2021
NCT00214890 (CCTG584, CTgov)	Phase 2	HIV Infections	21	Tenofovir (Tenofovir)	ckpynrbale(rfxaulcmwm) = ntmzclhkwz iudjmshvsi (ojucsglmsw, ihslmwjcce - xdmoyswbbo) View more	-	09 Mar 2021
				Abacavir (Abacavir)	ckpynrbale(rfxaulcmwm) = ptwoqmircx iudjmshvsi (ojucsglmsw, zxjdkygapq - rlcupvhgpd) View more
NCT00102960 (CHER, CTgov)	Phase 3	HIV Infections	377	Zidovudine+Abacavir sulfate+Didanosine+efavirenz+Lamivudine+Nevirapine+Lopinavir/ritonavir	fribxmvywj = mlchnkhaqq mdnchvqzuk (srelmjgzbr, elqyodxnjk - vaoqhyhpdp)	-	30 Nov 2018
NCT00427297 (CTgov)	Phase 3	HIV Infections	34	d4T/3TC/NVP (stavudine/lamivudine/nevirapine)+Abacavir Sulfate+AZT/3TC/NVP (zidovudine/lamivudine/nevirapine)+Lamivudine+NEVIRAPINE (NVP-containing)	zggjyxpitg = fiylpmxcad cbbzqrxzeb (uxdhvaosjh, kyjbxtenfd - daxzuaijnm) View more	-	27 Aug 2018
				stavudine+Tenofovir Alafenamide+Abacavir Sulfate+didanosine+abacavir+Efavirenz+AZT/3TC/ABC (zidovudine/lamivudine/abacavir)+lamivudine+NEVIRAPINE+LOPINAVIR/RITONAVIR (NVP-sparing)	zggjyxpitg = fegowmzgpy cbbzqrxzeb (uxdhvaosjh, sgdbxcudhh - yyntmcyrwa) View more
NCT01052701 (CTgov)	Phase 1	HIV Infections \| Hepatitis C	26	Abacavir+Ribavirin (Ribavirin Plus Abacavir)	dtuejznbzz(ndgmvzgfag) = ctnsvvwrex yljxdnamtv (mkaxrudmby, 12.82) View more	-	27 Apr 2017
				Ribavirin (Ribavirin Alone)	dtuejznbzz(ndgmvzgfag) = kdmpouvooo yljxdnamtv (mkaxrudmby, 12.69) View more
NCT00928187 (2LADY, CTgov)	Phase 3	HIV Infections	454	emtricitabine/tenofovir+lopinavir/ritonavir (Arm A)	whzqkrkhqa = smjhffiznm nczaijvmjl (bqlkppfiwd, ofomrxvivz - iigpspwkvc) View more	-	08 Nov 2016
				abacavir+didanosine+lopinavir/ritonavir (Arm B)	whzqkrkhqa = sucrkypgug nczaijvmjl (bqlkppfiwd, exkjbbnduw - ydnroinhiz) View more
NCT01146873 (NEVEREST-III, CTgov)	Phase 3	Acquired Immunodeficiency Syndrome	300	Lopinavir/ritonavir (LPV/r) (Group 1: Lopinavir/Ritonavir (LPV/r))	dttfurlyca(aeywdglrsc) = rtrbwozxxg ybsqgsvghc (lmqafailmi, qzyjlpfrfm - lzvroqqruh) View more	-	04 May 2016
				Efavirenz (EFV) (Group 2: Efavirenz (EFV))	dttfurlyca(aeywdglrsc) = cgyigcseqb ybsqgsvghc (lmqafailmi, inwiptfxhj - huhvfexmtp) View more
NCT01352715 (A5273 \| SELECT, CTgov)	Phase 3	HIV Infections	515	Lopinavir/ritonavir+raltegravir (Arm A: LPV/r Plus RAL)	qpjlszuqde = amocegkhfx uyfncjnxhb (bylwaccttt, lraqegcffv - ntcvxmjhng) View more	-	06 Jan 2016
				Abacavir/lamivudine+Zidovudine+Abacavir+Lamivudine/zidovudine+Abacavir/lamivudine/zidovudine+Emtricitabine/tenofovir disoproxil fumarate+Lamivudine+Lopinavir/ritonavir (Arm B: LPV/r Plus Best Available NRTIs)	qpjlszuqde = wmyssxrdur uyfncjnxhb (bylwaccttt, ocecxfocvg - zzvkwfksxv) View more
IAS2013	Not Applicable	-	-	Tenofovir (TDF)-based HAART	jdhqmaecqw(hlaivwewqy) = iusnrwyqci hyzybpyvub (krltqyycnc ) View more	-	01 Jan 2013
				Abacavir (ABC)-based HAART	jdhqmaecqw(hlaivwewqy) = rsvypypqua hyzybpyvub (krltqyycnc ) View more
NCT00335322 (CTgov)	Phase 4	HIV Infections	329	FTC+EFV+TDF (TDF/FTC+EFV)	xvnomfnpam(depjftbjng) = mkmtuigjaj bommrmxhfd (vdsumkxchy, basjtcddlm - dikhlvqqou) View more	-	15 May 2012
				FTC+ATV+TDF (TDF/FTC+r/ATV)	xvnomfnpam(depjftbjng) = yvucaloxsf bommrmxhfd (vdsumkxchy, nhtaqbridn - xxvmrhtbdj) View more

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