In: ClinicalTrials.gov. However . Bethesda (MD): National Library of Medicine (US). ILLUMINATE SWITCH A (MK-8591A-017; NCT04223778) and ILLUMINATE SWITCH B (MK-8591A-018; NCT04223791): Results for both of these Phase 3 trialsevaluating the doravirine/islatravir FDC in participants with viral suppression were announced in a company press release. Bethesda (MD): National Library of Medicine (US). Registered on November 2, 2021. It was tested on just 12 people, at two different concentrations. Registered on November 10, 2021. Two participants who received the highest dose of islatravir stopped treatment early because of a side effect; one participant experienced diarrhea, nausea, and vomiting, and one participant had an existing hepatitis B virus infection reactivate. Registered on December 2, 2020. Registered on January 15, 2020. Registered on September 1, 2017. Bethesda (MD): National Library of Medicine (US). Matthews RP, Jackson Rudd D, Zhang S, et al. One goal of HIV research is to identify new drugs that have fewer side effects. In: ClinicalTrials.gov. Islatravir for HIV treatment Study Identifiers: MK-8591-011; NCT03272347Sponsor: Merck Sharp & Dohme Corp.Phase: 2bStatus: This study was placed on partial clinical hold in December 2021. EFdA (4-ethynyl-2-fluoro-2-deoxyadenosine, MK-8591): a novel HIV-1 reverse transcriptase translocation inhibitor. An experimental inhibitor of nucleoside reverse transcriptase translocation, islatravir is being analysed to prevent and treat HIV-1. Bethesda (MD): National Library of Medicine (US). Islatravir, or EFdA (formerly known as MK-8591) is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI) with multiple mechanisms of action. 546. The FDAs decision was based on safety concerns over decreases in total lymphocyte and CD4 counts in some participants receiving islatravir in trials. Bethesda (MD): National Library of Medicine (US). Participants receiving ISL in prevention studies will no longer receive study drug; however, their CD4 and lymphocyte counts will continue to be monitored. It is being developed as a stand-alone agent and as part of a fixed-dose combination containing doravirine and islatravir (DOR/ISL). (Compound details obtained from ChemIDplus Advanced,1NIAID Therapeutics Database,2and Treatment Action Group Pipeline Report 20213,4), Mechanism of Action: Nucleoside reverse transcriptase translocation inhibitor (NRTTI). Islatravir - Merck Sharp & Dohme - AdisInsight Drug Profile Islatravir - Merck Sharp & Dohme Alternative Names: 4-ethynyl-2-fluoro-2-deoxyadenosine; EFdA; MK-8519; MK-8591; MK-8591-eluting implant; MK-8591D Latest Information Update: 10 Oct 2022 Price : $50 * Buy Profile Adis is an information provider. Bethesda (MD): National Library of Medicine (US). Islatravir, the first drug in its class, is being studied for both HIV treatment and prevention. Headache was more common in the combined ISL groups (11%) than in the DOR/3TC/TDF group (6%), and diarrhea was more common in the DOR/3TC/TDF group (16%) than in the combined ISL groups (7%). Participants who received ISL and MK-8507 will be followed for at least 6 months.17. . European AIDS Conference; October 27-30, 2021; Virtual and United Kingdom. Merck Sharp & Dohme Corp. A Phase 3 open-label rollover clinical study of doravirine/islatravir (DOR/ISL) once-daily for the treatment of HIV-1 infection in participants who previously received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL clinical study. Matthews RP, Jackson Rudd D, Fillgrove KL, et al. Drug-related AEs occurred in 8% of participants who received ISL and 19% of participants who received DOR/3TC/TDF. Registered on December 2, 2020. onchocerciasis, river blindness and belongs to the drug class anthelmintics. Participants are cisgender men who have sex with men and transgender women who have sex with men without HIV and who are at least 16 years of age and older. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Locations: Multiple countries, including United StatesPurpose: The purpose of this trial is to evaluate the safety and effectiveness of a switch from Biktarvy to an FDC containing doravirine/islatravir.7,15Selected Study Results: Results announced in an October 25, 2021 press release indicated that the doravirine/islatravir FDC was as effective as Biktarvy in controlling participants viral load levels. Roche maintains its position as the largest . ISL-TP inhibits HIV reverse transcriptase (RT) through multiple modes of action. Islatravir (MK-8591) is a potent anti-HIV-1 agent, acting as a nucleoside reverse transcriptase inhibitor, with EC50s of 0.068 nM, 3.1 nM and 0.15 nM for HIV-1 (WT), HIV-1 (M184V), HIV-1 (MDR), respectively. Description: Islatravir, also known as MK-8591 and EFdA, is a potential antiviral drug for the treatment of HIV infection. The majority of AEs were mild in intensity, with the most common AEs overall being headache, diarrhea, and nausea. After 24 weeks, eligible participants who were receiving ISL, DOR, and 3TC switched to a two-drug regimen of ISL plus DOR (Part 2). [3][4], Islatravir has activity against HIV in animal models,[5] and is being studied clinically for HIV treatment and prophylaxis. It is being developed as a stand-alone agent and as part of a fixed-dose combination containing doravirine and islatravir (DOR/ISL). [3] [4] Biological activity [ edit] Registered on September 13, 2021. Merck Sharp & Dohme Corp. A Phase 3, randomized, active-controlled, double-blind clinical study to evaluate a switch to doravirine/islatravir (DOR/ISL) once-daily in participants with HIV- 1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Merck: Press release, dated November 18, 2021. For more information about the clinical holds on trials evaluating islatravir, please refer to the drug developers December 13, 2021 press release.7, In this Phase 2b study, 8% of participants who received islatravir reported experiencing a drug-related side effect. Merck Sharp & Dohme Corp. A Phase 2b, randomized, active-controlled, double-blind, dose-ranging clinical study to evaluate a switch to islatravir (ISL) and MK-8507 once-weekly in adults with HIV-1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily. Merck Sharp & Dohme Corp. A Phase 3, randomized, active-controlled, double-blind clinical study to evaluate a switch to doravirine/islatravir (DOR/ISL) once-daily in participants with HIV- 1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF). Participants are cisgender women without HIV who are at least 16 years of age and older. [1] It is classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI). Merck Sharp & Dohme Corp. A Phase 2a, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of oral MK-8591 once-monthly in participants at low-risk for HIV-1 infection. Islatravir is in Phase 3 development for HIV treatment. In: ClinicalTrials.gov. Because islatravir may be coadministered with other antiretroviral agents, assessment of potential drugdrug interactions are warranted. Islatravir is a nucleoside that blocks the HIV enzyme reverse transciptase and traditionally, in medicinal chemistry, it's been hard to get the stereochemistry of nucleosides right, Huffman says. Results were compared with patients who received Delstrigo (n = 31), a three-drug combination of doravirine, lamivudine, and tenofovir disoproxil fumarate. NLM Identifier: NCT04564547. We do not sell or distribute actual drugs. Molina JM, Yazdanpanah Y, Afani Saud A, et al. Islatravir is an NRTTI (a nucleoside reverse transcriptase translocation inhibitor, a type of NTRI) that is being developed by Merck/MSD for both treatment and prevention. NIAID ChemDB, HIV Drugs in Development. The rate of drug-related AEs continued to be lower in the ISL groups (7.8%) than in the DOR/3TC/TDF group (22.6%). The Week 48 analysis found that 73% of participants who received any dose of ISL and 77% of participants who received DOR/3TC/TDF experienced at least one adverse event (AE). It has potent activity against HIV-1 and is also active against HIV-2 and multidrug-resistant HIV strains. Registered on February 26, 2021. and HIV and AIDS Clinical Trials fact sheets. In: ClinicalTrials.gov. Islatravir is a new antiretroviral drug currently in early stages of testing that researchers . Participants are treatment-naive adults with HIV. Week 48 data met safety and efficacy endpoints in adults with HIV-1 infection currently on antiretroviral therapy. Bethesda (MD): National Library of Medicine (US). NLM Identifier: NCT05130086. It acts as a nucleoside reverse transcriptase inhibitor (EC50s: 0.068 nM, 3.1 nM, and 0.15 nM for HIV-1 (WT), HIV-1 (M184V), HIV-1 (MDR), respectively). Conclusion: Next-generation radiopaque islatravir-eluting implants provide drug release projected to be sufficient for HIV prophylaxis for at least one year. -acting HIV treatments that combine Merck's investigational nucleoside reverse transcriptase translocation inhibitor islatravir and Gilead's investigational . Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Location: United StatesPurpose: The purpose of this study is to evaluate the efficacy of oral weekly islatravir in combination with the investigational capsid inhibitor lenacapavir in participants with viral suppression on Biktarvy.12Note: The developers of islatravir and lenacapavir announced in a December 13, 2021 press release that they were stopping dosing of participants in the GS-US-563-6041 trial. No serious AEs linked to the drug were reported so far. By Week 48, five participants who received ISL plus DOR had experienced protocol-defined virologic failure; however, all of these participants had HIV-1 RNA <80 copies/mL, and none met the criteria for resistance testing.12 No participants met the criteria for resistance testing through Week 144 of the trial.13. For more information about the clinical holds on trials evaluating islatravir, please refer to the drug developers December 13, 2021 press release.7, Islatravir for HIV treatment Study Names: MK-8591-011; NCT03272347Phase: 2bStatus: This study was placed on partial clinical hold in December 2021. Background: Islatravir is a nucleoside reverse transcriptase translocation inhibitor in development for the treatment and prevention of HIV-1 infection. Jefferys R. The PrEP and microbicides pipeline. Merck Sharp & Dohme Corp. A Phase 2 clinical study to evaluate the pharmacokinetics, safety, and efficacy of doravirine/islatravir in pediatric participants with HIV-1 infection who are virologically suppressed or treatment-nave, are less than 18 years of age, and weigh greater than or equal to 35 kg. https://www.treatmentactiongroup.org/wp-content/uploads/2021/07/pipeline_2021_hiv_ARV_final.pdf, https://www.treatmentactiongroup.org/wp-content/uploads/2021/07/pipeline_2021_hiv_PrEP_final.pdf, https://www.merck.com/news/merck-announces-clinical-holds-on-studies-evaluating-islatravir-for-the-treatment-and-prevention-of-hiv-1-infection/, https://clinicaltrials.gov/ct2/show/NCT03272347, https://clinicaltrials.gov/ct2/show/NCT04564547, https://www.merck.com/news/merck-provides-update-on-phase-2-clinical-trial-of-once-weekly-investigational-combination-of-mk-8507-and-islatravir-for-the-treatment-of-people-living-with-hiv-1/, https://clinicaltrials.gov/ct2/show/NCT05052996, https://clinicaltrials.gov/ct2/show/study/NCT04223778, https://www.merck.com/news/merck-announces-positive-top-line-results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-fixed-dose-combination-of-doravirine-islatravir-for-the-treatment-of-people-with-hiv-1/, https://clinicaltrials.gov/ct2/show/NCT04223791, https://clinicaltrials.gov/ct2/show/NCT04233216, https://clinicaltrials.gov/ct2/show/NCT04233879, https://clinicaltrials.gov/ct2/show/NCT04295772, https://clinicaltrials.gov/ct2/show/NCT04776252, https://clinicaltrials.gov/ct2/show/NCT04003103, https://clinicaltrials.gov/ct2/show/NCT05115838, https://clinicaltrials.gov/ct2/show/NCT05130086, https://clinicaltrials.gov/ct2/show/NCT04644029, https://clinicaltrials.gov/ct2/show/NCT04652700. Registered on September 21, 2020. It has potent activity against HIV-1 and is also active against HIV-2 and multidrug-resistant HIV strains.5,6, Intracellularly, ISL is converted to its active triphosphate form (ISL-TP). Get the latest public health information from CDC. Islatravir is in Phase 3 development for HIV treatment. 3,4 Islatravir belongs to a group of HIV drugs called nucleoside reverse transcriptase translocation inhibitors (NRTTIs). islatravir (4'-ethynyl-2-fluoro-2'-deoxyadenosine or EFdA) from the Yamasa Corporation based in Choshi, Japan. Safety, pharmacokinetics, and antiretroviral activity of islatravir (ISL, MK-8591), a novel nucleoside reverse transcriptase translocation inhibitor, following single-dose administration to treatment-naive adults infected with HIV-1: an open-label, phase 1b, consecutive-panel trial. Islatravir is a nucleoside reverse transcriptase translocation inhibitor, or NRTTI; if eventually approved, it would be the first such drug in its class. Experimental Code: MK-8591. Bethesda (MD): National Library of Medicine (US). [2] Merck is developing a subdermal drug-eluting implant to administer islatravir. Participants are adults with HIV who have been virologically suppressed on Biktarvy for at least 24 weeks before and at screening. In: ClinicalTrials.gov. Merck Sharp & Dohme Corp. A Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly as preexposure prophylaxis in cisgender men and transgender women who have sex with men, and are at high risk for HIV-1 infection. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this trial is to evaluate the safety and efficacy of ISL, DOR, and an FDC containing DOR/ISL, each compared to placebo, in heavily treatment-experienced participants.Study Population: Study Identifiers: ILLUMINATE NAIVE; MK-8591A-020; NCT04233879Sponsor: Merck Sharp & Dohme Corp.Phase: 3Status: This study was placed on partial clinical hold in December 2021. Islatravir/MK 8507 is a fixed dose combination being developed by Merck Sharp & Dohme. In: ClinicalTrials.gov. National Institute of Allergy and Infectious Diseases (NIAID). Participants have had viral suppression on Biktarvy with HIV RNA <50 copies/mL for at least the past 3 months. In: ClinicalTrials.gov. [1] It is classified as a nucleoside reverse transcriptase translocation inhibitor (NRTTI). It is often used with low doses of ritonavir or cobicistat to increase darunavir levels. Merck Sharp & Dohme Corp. A Phase 3 randomized, active-controlled, open-label clinical study to evaluate a switch to doravirine/islatravir (DOR/ISL) once-daily in participants with HIV-1 virologically suppressed on antiretroviral therapy. Islatravir is the first in a new class of ARVs, a nucleoside reverse transcriptase translocation inhibitor (NRTTI), to reach clinical trials. Registered on January 15, 2020. NLM Identifier: NCT04223778. NIAID ChemDB, HIV Drugs in Development. Abstract 551. The other is preventing unwanted side reactions. Early studies showed that a single 10-mg oral dose of islatravir produced antiviral effects for 10 days and that parenteral dosing as infrequently as once per year may be feasible. Merck Sharp & Dohme Corp. A Phase 2B, randomized, double-blind, active-comparator-controlled, dose-ranging clinical trial to evaluate the safety, tolerability, antiretroviral activity, and pharmacokinetics of MK-8591 given in combination with doravirine (DOR) and lamivudine (3TC) in HIV-1-infected treatment-nave adults. NLM Identifier: NCT04223778. In: ClinicalTrials.gov. ISL is a first-in-class nucleoside reverse transcriptase translocation inhibitor (NRTTI), explained Jean-Michel Molina, MD, PhD, of SaintLouis and Lariboisire Hospitals in Paris, France, at the. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2021. The IMPOWER 22 clinical trial is a Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly compared to once-daily emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) as pre-exposure prophylaxis (PrEP) in cisgender women at high risk for HIV-1 Infection. Bethesda (MD): National Library of Medicine (US). Merck Sharp & Dohme Corp. A Phase 2a, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of oral MK-8591 once-monthly in participants at low-risk for HIV-1 infection. Methods Class Alkynes; Antiretrovirals; Fluorinated hydrocarbons; Purine nucleosides; Small molecules . Type Small Molecule Groups Investigational Structure 3D https://www.treatmentactiongroup.org/wp-content/uploads/2021/07/pipeline_2021_hiv_ARV_final.pdf, https://www.treatmentactiongroup.org/wp-content/uploads/2021/07/pipeline_2021_hiv_PrEP_final.pdf, https://programme.ias2019.org/PAGMaterial/PPT/1878_4152/2019 IAS Presentation Molina MK-8591-011 48 wk FINAL 7-24-19 LOCKED.pptx, https://www.natap.org/2021/EACS/EACS_21.htm, https://www.merck.com/news/merck-announces-clinical-holds-on-studies-evaluating-islatravir-for-the-treatment-and-prevention-of-hiv-1-infection/, https://clinicaltrials.gov/ct2/show/NCT03272347, https://clinicaltrials.gov/ct2/show/NCT04564547, https://www.merck.com/news/merck-provides-update-on-phase-2-clinical-trial-of-once-weekly-investigational-combination-of-mk-8507-and-islatravir-for-the-treatment-of-people-living-with-hiv-1/, https://clinicaltrials.gov/ct2/show/NCT05052996, https://clinicaltrials.gov/ct2/show/study/NCT04223778, https://clinicaltrials.gov/ct2/show/NCT04223791, https://clinicaltrials.gov/ct2/show/NCT04233216, https://clinicaltrials.gov/ct2/show/NCT04233879, https://clinicaltrials.gov/ct2/show/NCT04295772, https://clinicaltrials.gov/ct2/show/NCT04776252, https://clinicaltrials.gov/ct2/show/NCT04003103, https://clinicaltrials.gov/ct2/show/NCT05115838, https://clinicaltrials.gov/ct2/show/NCT05130086, https://clinicaltrials.gov/ct2/show/NCT04644029, https://clinicaltrials.gov/ct2/show/NCT04652700, https://www.merck.com/news/merck-announces-positive-top-line-results-from-pivotal-phase-3-trials-evaluating-investigational-once-daily-oral-fixed-dose-combination-of-doravirine-islatravir-for-the-treatment-of-people-with-hiv-1/, https://idsa.confex.com/idsa/2018/webprogram/Paper71806.html. . The majority of side effects were mild in intensity, with the most common side effects overall being headache, diarrhea, and nausea. Molina J-M, Yazdanpanah Y, Afani A, et al. Herein, a case study is presented of a thermodynamically stable crystalline phase of the HIV drug Islatravir (MK-8591, EFdA) that was not isolated from initial pharmaceutical polymorph screening. Merck: Press release, dated October 25, 2021. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this open-label study is to evaluate the safety and tolerability of oral ISL administered once monthly in trans and gender diverse participants who are receiving gender-affirming hormone therapy and are at low risk of acquiring HIV.Study Population: Study Identifiers: IMPOWER 22; MK-8591-022; NCT04644029Sponsor: Merck Sharp & Dohme Corp.Phase: 3Status: This study was placed on full clinical hold in December 2021. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Location: Not availablePurpose: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of different doses of a once-yearly islatravir implant in participants who are at low risk of getting HIV.7,22, Study Names: MK-8591-035; NCT05130086Phase: 2Status: This study was placed on full clinical hold in December 2021. 1 2 US and European guidelines recommend ART regimens that generally consist of 3 drugs from at least 2 drug classes for the treatment of HIV-1 infection and 2-drug regimens as pre-exposure prophylaxis (PrEP) for prevention of HIV-1. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this open-label study is to evaluate the efficacy of oral weekly ISL in combination with the investigational capsid inhibitor lenacapavir in participants who are virologically suppressed on Biktarvy. [2] Merck is developing a subdermal drug-eluting implant to administer islatravir. https://chemdb.niaid.nih.gov/DrugDevelopmentHIV.aspx. Bethesda (MD): National Library of Medicine (US). NLM Identifier: NCT04223791. Bethesda (MD): National Library of Medicine (US). The FDAs decision was based on reports of decreases in total lymphocyte and CD4 counts in some participants receiving islatravir in trials. Michailidis E, Marchand B, Kodama EN, et al. The following studies have been placed on full clinical hold: MK-8591-016 - A Phase 2a PrEP study evaluating the safety and pharmacokinetics of oral islatravir once-monthly in participants at . MK-8591 does not alter the pharmacokinetics of the oral contraceptives ethinyl estradiol and levonorgestrel. There were few reports of drug-related side effects or discontinuations due to side effects associated with islatravir plus doravirine.9, Study Names: IMAGINE-DR; MK-8591-013; NCT04564547Phase: 2bStatus: See note below. Pharmacokinetic (PK) Parameter: Cmax of Islatravir (ISL) and Lenacapavir (LEN) [ Time Frame: Day 1 up to Week 36 ] Cmax is defined as the maximum observed . Additional trials evaluating doravirine/islatravir for HIV treatment are being conducted, including: Islatravir for HIV prevention Study Names: MK-8591-016; NCT04003103Phase: 2aStatus:This study was placed on full clinical hold in December 2021. Another four test subjects received a placebo, in an early study designed to assess the safety of . In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). NRTTIs use several different methods to block an HIV enzyme called reverse transcriptase. What side effects might islatravir cause? investigational new drug applications were halted for the oral and implant formulations of islatravir, a nucleoside reverse transcriptase translocation inhibitor, for pre-exposure prophylaxis. NLM Identifier: NCT04233879. Islatravir (ISL, MK-8591, EFdA, CAS: 865363-93-5) is an investigational antiviral drug developed by Merck for the treatment of HIV. Registered on June 27, 2019. Islatravir-TP inhibits reverse transcriptase to . Eight students stayed in one room, while in the other room, the principal allegedly stayed with the 17-year-old girl, a Class 11 student. Markowitz M, Sarafianos SG. Islatravir (MK-8591) is a highly potent type 1 human immunodeficiency virus (HIV . Arcus is expediting the development of first- or best-in-class medicines against . Generic Name Islatravir DrugBank Accession Number DB15653 Background Islatravir is under investigation in clinical trial NCT04233216 (Doravirine/islatravir (DOR/ISL) in Heavily Treatment-experienced (HTE) Participants for Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-019)). Where can I get more information about clinical trials studying islatravir? Jefferys R. The antiretroviral therapy pipeline 2021. Doravirine has distinguishing resistance pattern withing NNRTIs and is studying in association with islatravir [48-51]. Bethesda (MD): National Library of Medicine (US). For more details on the studies listed above, see the Health Professional version of this drug summary. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Not for Human or Veterinary or Therapeutic Use. There were no additional participants who discontinued treatment because of an AE.13, ILLUMINATE SWITCH A (MK-8591A-017; NCT04223778) and ILLUMINATE SWITCH B (MK-8591A-018; NCT04223791), In this Phase 2a trial evaluating ISL for PrEP, participants were randomized to once monthly oral doses of ISL 60 mg (n = 97), ISL 120 mg (n = 97), or placebo (n = 48). Webcast presented at: International Congress of Drug Therapy in HIV Infection (HIV Glasgow); October 28-31, 2018; Glasgow, United Kingdom. Approval Status: Experimental. Drug Class: Nucleoside/Nucleotide Reverse Transcriptase Inhibitors (NRTIs) Company: Merck & Company. A link to download a PDF version of the drug profile will be included in your email receipt. As testing of islatravir continues, additional information on possible side effects will be gathered. Participants are heavily treatmentexperienced children and adults with HIV who have been receiving the same ART regimen for at least the past 3 months. Islatravir, CAS 865363-93-5 Drug-reduced regimen could be used as well as new classes of antiretroviral drug, characterized by novel mechanisms of action proved their efficacy on heavily pretreated patient. In: ClinicalTrials.gov. Webcast presented at: International Congress of Drug Therapy in HIV Infection (HIV Glasgow); October 28-31, 2018; Glasgow, United Kingdom. A subdermal implant of the HIV-1 antiretroviral islatravir delivers sustained drug release over 12 weeks in humans. ChemIDplus Advanced: Islatravir. Islatravir is an effective anti-HIV-1 agent. Registered on March 3, 2020. In: ClinicalTrials.gov. This study was placed on full clinical hold in December 2021. Primarily, ISL-TP functions as an immediate chain terminatorafter ISL is incorporated into viral DNA, it blocks RT translocation and prevents nucleotide attachment onto the viral DNA chain. Registered on September 13, 2021. The two-drug regimen was also comparable in efficacy to Delstrigo (doravirine/ tenofovir disoproxil fumarate/lamivudine). These promising results have been extended in small studies of islatravir for HIV prevention and treatment that were presented at IAS 2019. Schrmann D, Rudd DJ, Zhang S, et al. The safety of doravirine/islatravir was similar to what had previously been reported in Phase 2 studies.14, Study Names: ILLUMINATE HTE; MK-8591A-019; NCT04233216Phase: 3Status: This study was placed on partial clinical hold in December 2021. Participants are at low risk of acquiring HIV. [2] Merck is developing a subdermal drug-eluting implant to administer islatravir. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Locations: Multiple countries, including United StatesPurpose: The purpose of this trial is to evaluate the safety and effectiveness of a switch from a current ART regimen to a fixed-dose combination (FDC) containing doravirine/islatravir.7,13Selected Study Results: Results announced in an October 25, 2021 press release indicated that the doravirine/islatravir FDC was as effective as other ART regimens in controlling participants viral load levels. Islatravir is an investigational drug that is being studied to treat and prevent HIV infection. Study Identifiers: GS-US-563-6041; NCT05052996Sponsor: Gilead Sciences Phase: 2Status: See note below. Islatravir is also in Phase 3 development for HIV prevention. First, they needed to edit the enzymes to accept their intermediates. Conference Reports for National AIDS Treatment Advocacy Project (NATAP); 2021. To do so, the overall amounts and proportions of various classes of immunocytes in the . Merck Sharp & Dohme Corp. A Phase 2b, randomized, active-controlled, double-blind, dose-ranging clinical study to evaluate a switch to islatravir (ISL) and MK-8507 once-weekly in adults with HIV-1 virologically suppressed on bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) once-daily. We aimed to assess the efficacy and safety of islatravir-based regimens for the treatment of HIV-1. For more information, visit NIH Clinical Research Trials and You. NLM Identifier: NCT04652700. Bethesda (MD): National Library of Medicine (US). [7] Nevertheless, there are HIV strains resistant to islatravir and research is ongoing. By blocking reverse transcriptase, NRTTIs prevent HIV from multiplying and can reduce the amount of HIV in the body.5, Islatravir may be effective against certain HIV strains that are resistant to other HIV drugs.6. On December 13, 2021, the U.S. FDA placed clinical holds on studies of islatravir for HIV treatment and prevention. Most of the cases of headache and diarrhea were mild, transient, and unrelated to treatment.15,16, Results through Week 144 of the MK-8591-011 study include data from the open-label maintenance phase of the trial where all participants in the ISL plus DOR groups transitioned to the selected ISL dose of 0.75 mg plus DOR 100 mg (Part 3). For more information about the clinical holds on trials evaluating islatravir, please refer to the drug developers December 13, 2021 press release.14, In this Phase 2b study, 90 participants received ISL (in doses of 0.25 mg, 0.75 mg, or 2.25 mg) plus DOR and 3TC and 31 participants received DOR/3TC/TDF for 24 weeks (Part 1). Advances in antiretroviral therapy (ART) have contributed significantly to the reduction in morbidity, mortality, and transmission of HIV-1. Grobler J. Efficacy of MK-8591 against diverse HIV-1 subtypes and NRTI-resistant clinical isolates. Mechanism of inhibition of HIV-1 reverse transcriptase by 4-ethynyl-2-fluoro-2-deoxyadenosine triphosphate, a translocation-defective reverse transcriptase inhibitor. Treatment Action Group Pipeline Report 2021. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of two different doses of oral ISL administered once monthly to participants who are at low risk of acquiring HIV.Study Population: Study Identifiers: MK-8591-043; NCT05115838Sponsor: Merck Sharp & Dohme Corp.Phase: 2aStatus: This study was placed on full clinical hold in December 2021. Bethesda (MD): National Library of Medicine (US). Bethesda (MD): National Library of Medicine (US). Participants are adults with HIV who have been receiving Biktarvy for at least the past 3 months. . NLM Identifier: NCT04776252. Merck Sharp & Dohme Corp. Merck Sharp & Dohme Corp. A Phase 2a, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of a radiopaque matrix MK-8591 implant in participants at low-risk for HIV-1 infection. In: ClinicalTrials.gov. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this study is to evaluate the safety and efficacy of oral ISL administered once monthly as PrEP in cisgender men who have sex with men and transgender women who have sex with men and who are at high risk of acquiring HIV.Study Population: Additionally, an injectable formulation of ISL is being evaluated in a Phase 1 trial (MK-8591-034). Gilead Sciences. Nucleoside Reverse Transcriptase Translocation Inhibitors. Chemical Structure Islatravir CAS# 865363-93-5 Product data Instruction Theoretical Analysis MedKoo Cat#: 528101 Name: Islatravir CAS#: 865363-93-5 Chemical Formula: C12H12FN5O3 Exact Mass: 293.0924 Molecular Weight: 293.2584 Merck Sharp & Dohme Corp. A Phase 3, randomized, clinical study in HIV-1-infected heavily treatment-experienced participants evaluating the antiretroviral activity of blinded islatravir (ISL), doravirine (DOR), and doravirine/islatravir (DOR/ISL), each compared to placebo, and the antiretroviral activity, safety, and tolerability of open-label DOR/ISL. Merck announces clinical holds on studies evaluating islatravir for the treatment and prevention of HIV-1 infection. Some clinical trials may be looking for volunteer participants. Participants who started treatment in ongoing studies of doravirine/islatravir will continue receiving study drugs; however, no new participants will be screened or randomized in doravirine/islatravir studies. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this trial is to evaluate the safety and efficacy of an FDC containing DOR/ISL versus Biktarvy in treatment-naive participants.Study Population: Additional trials evaluating DOR/ISL for HIV treatment are being conducted, including: Islatravir for HIV prevention Study Identifiers: MK-8591-016; NCT04003103Sponsor: Merck Sharp & Dohme Corp.Phase: 2aStatus: This study was placed on full clinical hold in December 2021. Get access to cutting edge treatment via FTC/TDF, Placebo to ISL, Placebo to FTC/TDF, Islatravir. In: ClinicalTrials.gov. The initial focus of this col- . Merck Sharp & Dohme Corp. A Phase 2 open-label study to evaluate the safety and pharmacokinetics of oral islatravir once-monthly in trans and gender diverse individuals on gender-affirming hormone therapy and at low-risk for HIV-1 infection. A Phase 2 randomized, open-label, active-controlled study evaluating the safety and efficacy of an oral weekly regimen of islatravir in combination with lenacapavir in virologically suppressed people with HIV. co-commercialize lenacapavir and islatravir (a nucleoside reverse transcriptase translocation inhibitor) for the treat-ment of patients with HIV [6]. Hillier S, Bekker L-G, Riddler SA, et al. A Phase 1 study to evaluate the drug interaction between islatravir (MK-8591) and doravirine in adults without HIV. Treatment Action Group Pipeline Report 2021. Participants have HIV RNA 1,000 copies/mL and CD4 counts 200 cells/mm. Participants have been sexually active with male or transgender women partners in the past month before screening and are at high risk of acquiring HIV. Grobler J. Efficacy of MK-8591 against diverse HIV-1 subtypes and NRTI-resistant clinical isolates. Biktarvy is a complete HIV treatment that combines three powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Islatravir-eluting implants appear to be well tolerated, and the results from this trial support further study of these implants in a larger, longer Phase 2 trial. Participants receiving islatravir in prevention studies will no longer receive study drug; however, their CD4 and lymphocyte counts will continue to be monitored. Registered on January 8, 2020. Merck Sharp & Dohme Corp. A Phase 3 open-label rollover clinical study of doravirine/islatravir (DOR/ISL) once-daily for the treatment of HIV-1 infection in participants who previously received DOR/ISL in a Phase 2 or Phase 3 DOR/ISL clinical study. Skip to content Client Portal HIV & STI Testing PrEP & PEP Syringe Services Calendar Services & Communities Services Communities Connect QTPOC at Strut Get Involved Be an Advocate Support Our Work Work With Us In: ClinicalTrials.gov. Merck Sharp & Dohme Corp. A Phase 3, randomized, active-controlled, double-blind clinical study to evaluate the efficacy and safety of oral islatravir once-monthly as preexposure prophylaxis in cisgender women at high risk for HIV-1 infection. . This suggests that hormonal contraceptives that contain LNG or EE can be used in individuals who are taking ISL.36. The US Food and Drug Administration (FDA) has placed clinical holds on trials analysing Merck's (MSD) islatravir (MK-8591) for human immunodeficiency virus 1 (HIV-1) treatment. Merck is investigating it both as a treatment for HIV and for prevention of the virus. Markowitz M, Sarafianos SG. NLM Identifier: NCT03272347. Where can I get more information about clinical trials studying islatravir? Islatravir in combination with doravirine for treatment-naive adults with HIV-1 infection receiving initial treatment with islatravir, doravirine, and lamivudine: a phase 2b, randomised, double-blind, dose-ranging trial. Islatravir Is Not Expected to Be a Victim or Perpetrator of Drug-Drug Interactions via Major Drug-Metabolizing Enzymes or Transporters . NRTTIs use several different methods to block an HIV enzyme called reverse transcriptase. But this is something enzymes are designed by nature to do. (A clinical hold is an order given by FDA to a drug sponsor to delay or suspend clinical trial work under an investigational new drug application (IND). The apparent terminal half-life of ISL-TP was 177 to 209 hours.9, In a Phase 1b trial (NCT02217904) evaluating single oral doses of ISL (0.5 to 30 mg) in treatment-naive adults, the intracellular half-life of ISL-TP ranged from 78.5 to 128 hours.10, Metabolism/Elimination: In vitro studies indicate that ISL undergoes adenosine deaminase-mediated metabolism and renal excretion; hepatic metabolism, however, does not appear to have a significant role in ISL elimination.11, Resistance: A Phase 2b trial (NCT03272347) evaluated three doses of ISL that were administered in combination with doravirine (DOR) in treatment-naive individuals. In the first part of the study, the islatravir plus doravirine arms also had lamivudine (3TC, Epivir) on board until week 24, at which time participants with an undetectable viral load dropped the 3TC and coasted along with the other two drugs. In total five Islatravir phases are identified: one monohydrate and four anhydrate phases. Merck: Press release, dated November 18, 2021. MK 8507 is a orally-administered, non-nucleoside reverse . Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of different doses of a once-yearly ISL implant in participants who are at low risk of acquiring HIV.Study Population: Study Identifiers: MK-8591-035; NCT05130086Sponsor: Merck Sharp & Dohme Corp.Phase: 2Status: This study was placed on full clinical hold in December 2021. In: ClinicalTrials.gov. No serious drug-related side effects were reported.21, Study Names: MK-8591-043; NCT05115838Phase: 2aStatus: This study was placed on full clinical hold in December 2021. Generic Version Available: No. United States National Library of Medicine. IAS Conference on HIV Science; July 18-22, 2021; Virtual and Berlin, Germany. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Study Purpose: The purpose of this study is to evaluate the safety and efficacy of oral ISL administered once monthly as PrEP in cisgender women who are at high risk of acquiring HIV.Study Population: Study Identifiers: IMPOWER 24; MK-8591-024; NCT04652700Sponsor: Merck Sharp & Dohme Corp.Phase: 3Status: This study was placed on full clinical hold in December 2021. In both cases, the active comparator group will receive DOR/3TC/TDF.Study Population: Study Identifiers: IMAGINE-DR; MK-8591-013; NCT04564547Sponsor: Merck Sharp & Dohme Corp.Phase: 2bStatus: See note below. Merck announces clinical holds on studies evaluating islatravir for the treatment and prevention of HIV-1 infection. Two participants who received the 2.25-mg dose of ISL discontinued treatment because of an AE; one participant experienced diarrhea, nausea, and vomiting, and one participant had HBV reactivation. (Compound details obtained from ChemIDplus Advanced,1NIAID Therapeutics Database,2and Treatment Action Group Pipeline Report 20213,4), Islatravir is an investigational drug that is being studied to treat and prevent HIV infection.3,4, Islatravir belongs to a group of HIV drugs called nucleoside reverse transcriptase translocation inhibitors (NRTTIs). Participants have no known resistance to any approved HIV-1 reverse transcriptase inhibitor or any study intervention. Participants who received islatravir and MK-8507 will be followed for at least 6 months.10, Study Names: GS-US-563-6041; NCT05052996Phase: 2Status: See note below. Ankrom W, Jonathan D, Rudd D, et al. About Lenacapavir Lenacapavir is a novel investigational capsid inhibitor that interrupts the activity of HIV capsid, a protein that surrounds and protects the virus' genetic material and essential enzymes. adults with HIV-1 infection who are virologically suppressed will resume under an amended protocol with a lower dose of islatravir. Registered on January 15, 2020. Registered on September 1, 2017. The latest clinical holds are on the investigational new drug applications (INDs) for the oral and implant formulations of islatravir for HIV-1 PrEP; the injectable formulation of islatravir. Bethesda (MD): National Library of Medicine (US). Long-acting HIV therapies are the next frontier in the disease, with companies citing . NLM Identifier: NCT04295772. Reblozyl is a first-in-class erythroid maturation recombinant fusion protein obtained as part of . The FDAs decision was based on safety concerns over decreases in total lymphocyte and CD4 counts in some participants receiving islatravir in trials. In: ClinicalTrials.gov. NLM Identifier: NCT04644029. Treatment resistant depression MK-1942. Safety and pharmacokinetics of once-daily multiple-dose administration of islatravir in adults without HIV. Please refer to the ClinicalTrials.gov record and/or the drug developers website for updates on this studys status.Locations: Multiple countries, including United StatesPurpose: The purpose of this trial is to evaluate the safety and efficacy of an FDC containing doravirine/islatravir versus Biktarvy in adults with HIV who have never taken HIV medicines before.7,17. What is the largest pharmaceutical company in the world? [2] Merck is developing a subdermal drug-eluting implant to administer islatravir. Registered on November 10, 2021. 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