Drug information

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Pronounce:
Other 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,and Entyvio Full Prescribing Information3)

What is vedolizumab?What is vedolizumab?

What is vedolizumab?

Vedolizumab is an investigational drug that is being studied to treat HIV infection.4,5 Vedolizumab (brand name: Entyvio) is also currently approved by the U.S. Food and Drug Administration (FDA) to treat ulcerative colitis 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 cell receptor called 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 their viral load levels.4,5

To learn about how investigational drugs are tested during clinical trials, read the HIVinfo What is an Investigational HIV Drug? and HIV/AIDS Clinical Trials fact sheets.

Which clinical trials are studying vedolizumab?Which clinical trials are studying vedolizumab?

Which clinical trials are studying vedolizumab?

Study Name: NCT03577782
Phase: 1/2
Status: This study is currently recruiting participants.
Location: Spain
Purpose: The purpose of this study is to evaluate whether vedolizumab plus antiretroviral therapy (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
Phase: 2
Status: This study is currently recruiting participants.
Location: Canada
Purpose: The purpose of this trial is to evaluate vedolizumab’s safety and ability to control viral load levels in individuals with chronic HIV infection undergoing a treatment interruption of ART.5

A Phase 1 study (NCT02788175) evaluating the effectiveness of vedolizumab on controlling viral rebound 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?What side effects might vedolizumab cause?

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 intravenous 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 hepatitis 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?Where can I get more information about clinical trials studying vedolizumab?

Where can I get more information about clinical trials studying vedolizumab?

More information about vedolizumab-related research studies is available from ClinicalTrials.gov.

Some clinical trials may be looking for volunteer participants. Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.

ReferencesReferences

References

  1. United States National Library of Medicine. ChemIDplus Advanced: Vedolizumab. https://chem.nlm.nih.gov/chemidplus/rn/943609-66-3. Accessed October 14, 2019
  2. Treatment Action Group website. Research toward a cure trials. http://www.treatmentactiongroup.org/cure/trials. Accessed October 14, 2019
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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. Accessed October 14, 2019

Last Reviewed: October 14, 2019