Drug Database: Vedolizumab

What is vedolizumab?

Vedolizumab is currently approved by the U.S. Food and Drug Administration (FDA) under the brand name Entyvio for the treatment of ulcerative colitis and Crohn’s disease.³  Vedolizumab is also being studied as an investigational drug to treat HIV infection.²

As an investigational HIV drug, vedolizumab belongs to a group of drugs called α₄β₇ integrin antagonists. α_₄β_₇ integrin antagonists block an immune cell receptor called α_₄β_₇.³ The α_₄β_₇ receptor is thought to have an important role in directing HIV into gut tissues.⁴

Researchers are currently studying whether vedolizumab can help people with HIV maintain control of their viral load levels.^5–7 

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

Select clinical trials of vedolizumab

Study Name: NCT03577782

Phase: 2
Status: This study has been completed.
Location: Spain
Purpose: The purpose of this study was to evaluate the safety of vedolizumab and whether vedolizumab plus antiretroviral therapy (ART) could help people who were treatment-naive control viral load levels during an analytical treatment interruption of ART.^2,5,8
Selected Study Results: Results presented at CROI 2022 showed that although vedolizumab was safe and well-tolerated, it had no substantial impact on viral remission after participants underwent an analytical treatment interruption of ART.⁹
Additional Published Material:

• GeSIDA, 2019 (abstract PO-48): Safety and efficacy of vedolizumab combined with antiretroviral therapy to achieve permanent virological remission in HIV-infected subjects without previous antiretroviral therapy

Study Names: HAVARTI; NCT03147859

Phase: 2
Status: The status of this study is unknown.
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 an analytical treatment interruption of ART.⁶
Selected Study Results: Results presented at CROI 2019 showed that vedolizumab given at two different doses and administered both before and after an analytical treatment interruption of ART was generally safe. No drug-related severe side effects were reported. No participants had sustained viral suppression after treatment interruption of ART. Notably, the higher dose of vedolizumab appeared to have a significantly greater effect on reducing viral rebound compared with the lower dose of vedolizumab.¹⁰

Study Names: (1) EHVA T02/ANRS VRI07; NCT04120415 and (2) AMEP-EHVA T02; NCT05280392

Phase: The EHVA T02/ANRS VRI07 study is a Phase 2 trial. The AMEP-EHVA T02 study is an observational trial.
Status: ​​​​​​​These studies are currently recruiting participants.
Locations: EHVA T02/ANRS VRI07 study — France, Switzerland, and United Kingdom.  AMEP-EHVA T02 study — Switzerland.
Purpose: The purpose of the EHVA T02/ANRS VRI07 study is to evaluate the ability of vedolizumab given with and without the therapeutic HIV vaccine MVA HIV-B in controlling viral load levels in people undergoing an analytical treatment interruption of ART. The AMEP-EHVA T02 study is a follow-on trial evaluating the experience of people who were offered to participate in the EHVA T02/ANRS VRI07 trial.^7,11

For more details on the studies listed above, see the Health Professional version of this drug summary.

A Phase 1 study (NCT02788175) evaluating the effectiveness of vedolizumab on controlling viral rebound in individuals undergoing an analytical treatment interruption of ART has also been completed, and results are available from Science Translational Medicine (2019).¹² 

What side effects might vedolizumab cause?

One goal of HIV research is to identify new drugs that have fewer side effects. The following side effects were observed in some of the studies of vedolizumab listed above.

NCT03577782

In this Phase 2 study, ten participants were enrolled, and six participants completed 24 weeks of treatment with vedolizumab plus ART, followed by an analytical treatment interruption of ART. Vedolizumab was reported as being well tolerated. No serious side effects occurred throughout the study period.^5,8,9

HAVARTI (NCT03147859)

In this Phase 2 study, eight adults with HIV received intravenous infusions of vedolizumab. Vedolizumab was administered both before and after an analytical treatment interruption of ART. No drug-related severe side effects were reported. Influenza and severe short-term hepatitis each occurred in one participant.^6,10

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.

Additional information on side effects known to be associated with vedolizumab can be found in the FDA-approved Full Prescribing Information for Entyvio.³

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

More information about vedolizumab-related research studies is available from ClinicalTrials.gov. (The ClinicalTrials.gov search can be modified so that you can get results that better match your interests. To learn more about the ClinicalTrials.gov search features, please see How to Search.)

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.

References

1. National Center for Biotechnology Information. PubChem substance record for SID 472387049, vedolizumab, Source: FDA Global Substance Registration System (GSRS). Accessed February 12, 2023
2. Treatment Action Group website. Research toward a cure trials. Accessed February 12, 2023
3. Takeda Pharmaceuticals America, Inc. Entyvio: full prescribing information, October 24, 2022. DailyMed. Accessed February 12, 2023
4. Uzzan M, Tokuyama M, Rosenstein AK, et al. Anti-α4β7 therapy targets lymphoid aggregates in the gastrointestinal tract of HIV-1–infected individuals. Sci Transl Med. 2018;10(461). doi:10.1126/scitranslmed.aau4711. Accessed February 12, 2023
5. 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. Accessed February 12, 2023
6. 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. Accessed February 12, 2023
7. ANRS, Emerging Infectious Diseases. EHVA T02 (European HIV Vaccine Alliance Therapeutic Trial 02)/ANRS VRI07: a Phase II randomised, placebo-controlled trial of vedolizumab with or without therapeutic HIV MVA vaccine in individuals who started antiretrovirals during primary or chronic Infection. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on September 30, 2019. NLM Identifier: NCT04120415. Accessed February 12, 2023
8. Jimenez-Leon MR, Gasca Capote C, Espinosa N, et al. Safety and efficacy of vedolizumab combined with antiretroviral therapy to achieve permanent virological remission in HIV-infected subjects without previous antiretroviral therapy. Presented at: XI Congreso Nacional GeSIDA; December 10-13, 2019; Toledo, Spain. Abstract PO-48. Accessed February 12, 2023
9. Jiménez-León MR, Gasca-Capote C, Roca-Oporto C, et al. Phase 2 clinical trial of vedolizumab and ART in subjects with no previous ART. Poster presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 12-16, 2022; Virtual. Poster 359. Accessed February 12, 2023
10. 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 February 12, 2023
11. ANRS, Emerging Infectious Diseases. Expectation, motivation and experience of HIV-patients regarding participation to the EHVA T02/ANRS VRI 07 HIV cure-related clinical trial (AMEP-EHVA T02). In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on February 11, 2022. NLM Identifier: NCT05280392. Accessed February 12, 2023
12. 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. Accessed February 12, 2023