VedolizumabOther Names: Entyvio, VDZ Drug Class: a4ß7 Integrin Antagonist Molecular Formula: C6528 H10072 N1732 O2042 S42 Registry Number: 943609-66-3 (CAS) Chemical Name: Immunoglobulin G1, anti-(human integrin LPAM-1 (lymphocyte Peyer's patch adhesion molecule 1)) (human-Mus musculus heavy chain), disulfide with human-Mus musculus kappa-chain, dimer Organization: Takeda Pharmaceuticals America, Inc. Phase of Development: Vedolizumab is in Phase 2 development for HIV treatment.
(Compound details obtained from ChemIDplus Advanced,1 Treatment Action Group website,2 and Entyvio Full Prescribing Information3)
What is vedolizumab?
Vedolizumab is anthat is being studied to treat HIV .4,5 Vedolizumab (brand name: Entyvio) is also currently approved by the U.S. (FDA) to treat ulcerative and Crohn’s disease.3
As an investigational HIV drug, vedolizumab belongs to a group of drugs called α4β7 integrin antagonists. α4β7 integrin antagonists block an immune cellcalled α4β7.3 The α4β7 receptor is thought to have an important role in directing HIV into gut tissues.6
Researchers are currently studying whether vedolizumab can help people with HIV maintain control of theirlevels.4,5
Which clinical trials are studying vedolizumab?
Study Name: NCT03577782
Status: This study is currently recruiting participants.
Purpose: The purpose of this study is to evaluate whether vedolizumab plus (ART) can help people who have never taken HIV medicines control their viral load levels during a treatment interruption of ART.4
Study Names: HAVARTI; NCT03147859
Status: This study is currently recruiting participants.
Purpose: The purpose of this trial is to evaluate vedolizumab’s safety and ability to control viral load levels in individuals with undergoing a treatment interruption of ART.5
A Phase 1 study (NCT02788175) evaluating the effectiveness of vedolizumab on controlling in individuals undergoing a treatment interruption of ART has also been completed.7
For more details on the studies listed above, see the Health Professional version of this drug summary.
What side effects might vedolizumab cause?
One goal of HIV research is to identify new drugs that have fewer side effects. In the Phase 2 HAVARTI trial (NCT03147859), eight adults with HIV received infusions of vedolizumab. Vedolizumab was administered both before and after treatment interruption of ART. No drug-related severe side effects were reported. Influenza and severe each occurred in one participant.5,8
Additional information on side effects known to be associated with vedolizumab can be found in the FDA-approved Full Prescribing Information for Entyvio.
Because vedolizumab is still being studied, information on possible side effects of the drug is not complete. As testing of vedolizumab continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying vedolizumab?
More information about vedolizumab-related research studies is available from the database of study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a NIH Clinical Research Trials and You.is right for you. For more information, visit
- United States National Library of Medicine. ChemIDplus Advanced: Vedolizumab. https://chem.nlm.nih.gov/chemidplus/rn/943609-66-3. Accessed October 14, 2019
- Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed October 14, 2019
- Takeda Pharmaceuticals America, Inc. Entyvio: full prescribing information, June 2019. DailyMed. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6e94621c-1a95-4af9-98d1-52b9e6f1949c. Accessed October 14, 2019
- Hospitales Universitarios Virgen del Rocío. Phase II clinical trial to analyze the safety and efficacy of vedolizumab combined with antiretroviral therapy to achieve permanent virological remission in HIV-infected subjects without previous antiretroviral therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on June 12, 2018. NLM Identifier: NCT03577782. https://clinicaltrials.gov/ct2/show/NCT03577782. Accessed October 14, 2019
- Ottawa Hospital Research Institute. Vedolizumab treatment in antiretroviral drug treated chronic hiv infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on April 3, 2017. NLM Identifier: NCT03147859. https://clinicaltrials.gov/ct2/show/NCT03147859. Accessed October 14, 2019
- Uzzan M, Tokuyama M, Rosenstein AK, et al. Anti-α4β7 therapy targets lymphoid aggregates in the gastrointestinal tract of HIV-1 infected individuals. bioRxiv. June 2018:346684. doi:10.1101/346684
- National Institute of Allergy and Infectious Diseases (NIAID). An exploratory, open-label study of vedolizumab (anti-alpha4beta7 antibody) in subjects with HIV infection undergoing analytical treatment interruption. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 28, 2016. NLM Identifier: NCT02788175. https://clinicaltrials.gov/ct2/show/NCT02788175. Accessed October 14, 2019
- McGuinty M, Angel J, Kumar A, et al. Seeking suppression in HAVARTI: viremia & T cells after vedolizumab & ATI in HIV/ART. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); March 4-7, 2019; Seattle, WA. Poster 393. http://www.croiconference.org/sites/default/files/posters-2019/1430_McGuinty_0393.pdf. Accessed October 14, 2019
Last Reviewed: October 14, 2019
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