HIV InfectionsPhase 1/2NCT03577782
Vedolizumab Treatment in HIV-Infected Subjects Without Previous Antiretroviral Therapy
A Phase 1/2 study testing Entyvio (Vedolizumab) in people with HIV Infections, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Entyvio (Vedolizumab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2018to May 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with documented HIV-infection. Aged, 18 - 65 years.
- HIV-RNA >1x10e4 copies/mL.
- CD4+ T-cell counts >350 cells//μL
- To accept analytical ART interruption.
Who cannot join
- Presence of major resistance mutations to the antiretrovirals used.
- Active opportunistic infections.
- Pregnancy or breastfeeding
- Active hepatitis C or B virus infection.
- Active or latent tuberculosis not treated.
- Cirrhosis, portal hypertension and/or hypersplenism of any etiology.
Show all 14Show fewer
- Current or past neoplasia susceptible to be treated with steroids, immunotherapy or chemotherapy.
- Abnormal laboratory measurements grade 3 or 4.
- Concomitant use of drugs with pharmacological interactions with the treatment of the study based on the technical data sheet of the products.
- Creatinine clearance <50mL/min.
- Any type of vaccination (e.g., hepatitis B virus, influenza…) two weeks before the beginning of the study.
- Cardiovascular disease (e.g., acute coronary syndrome, heart failure…).
- Neurological or neuro psychiatric disorder which symptoms may interfere with the safety and tolerability analysis.
- Alcohol abuse and/or drugs that may interfere with the study treatment.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Virgen del Rocío University Hospital
Seville, 41013
Sofia Rubio, PhD, +34955012010, sofia.rubio.exts@juntadeandalucia.es; ezequiel.ruizmateos@gmail.com
Ezequiel Ruiz-Mateos
About this study
Official title: 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
HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART. New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed. In monkeys infected with SIV, the analog of HIV, the virus has disappeared from the blood after administration of a compound and cessation of ART. There is an equivalent compound in humans called Vedolizumab. The aim of the present study is to research if Vedolizumab combined with ART, in subjects without previous ART, is able to eliminate the virus from the blood after ART is not taken.
Read the detailed description
HIV cannot be eradicated and keep latent in anatomical and cellular reservoirs. In fact, patients undergoing antiretroviral treatment (ART) interruption rapidly experience plasma viral load rebound. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the eradication or permanent remission of plasma viral load, also known as functional cure, in the absence of ART, as occurs in persistent HIV controllers. In this scenario, new drugs associated to ART that allow the achievement of permanent plasma viral remission after ART withdrawn are needed.
The main targets of HIV infection are the memory CD4+ T-cells. This cell subset is mainly located in gut associated lymphoid tissue (GALT). These lymphocytes are recruited to the gut thanks to the expression of the integrin α4β7. The Env protein gp120 binds to α4β7 and enable the dissemination of HIV in the gut. At the same time the envelope of HIV is enriched in α4β7 coming from the plasma membrane of the host cells favoring its pathogenicity. Recently, the administration of a monoclonal antibody against α4β7 was shown to achieve significant protection for HIV transmission before and after low dose intravaginal inoculation of SIV in Rhesus Macaques. Surprisingly, long-term virological protection has been documented in SIV-infected macaques after ART interruption after administration and withdrawal of the monoclonal antibody against α4β7. The mechanisms through which this antibody has achieved the permanent remission of plasma viral load are not fully understood. The success of these findings in the simian model makes the antibody against α4β7 a good candidate as ART adjuvant with the aim to reach a functional cure and/or persistent virological remission in humans. Currently, there is a monoclonal antibody against α4β7 with known safety and security profiles in humans, this antibody is commercially available under the name of Vedolizumab. This antibody is used for the treatment of ulcerative colitis and Crohn Disease. In fact, there are already two clinical trials that are using Vedolizumab in HIV-infected patients (NCT02788175 y NCT03147859). In these clinical trials Vedolizumab is administered in the chronic phase of the infection in subjects with undetectable viral load during at least two years on ART. There are not clinical trials administering Vedolizumab in early stages of infection in naïve HIV-infected subjects for ART. Potentially, this strategy of early antibody treatment may increase the success of the therapy and decrease the time on ART of the individuals. The aim of the present clinical trial is to evaluate the safety and efficacy of Vedolizumab combined with ART to achieve permanent virological remission in naïve HIV-infected individuals after ART interruption.
- Conditions
- HIV Infections
- Being tested
- Entyvio (Vedolizumab)
- Keywords
- HIV, CD4+, T-cell, Reservoir, Cure, Antiretroviral therapy, Vedolizumab, Gut, Alpha4Beta7, gp120, Interruption
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entyvio (Vedolizumab)Biological
- Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks.
- Entyvio (Vedolizumab) (300mg), 7 intravenous infusions at week 0 (baseline) (concomitant with ART onset), 4, 8, 12, 16, 20 and 24.
At week 24 ART and Vedolizumab administration will be interrupted. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements).
Patients will be followed up until week 48.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | HIV-infected subjects with no previous ART will begin ART together with Vedolizumab infusions at week 0, 4, 8, 12, 16, 20 and 24 weeks. At this time point ART and Vedolizumab treatment will be interrupted. Patients will be followed up until week 48. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements). Receives: Biological: Entyvio (Vedolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
The number of adverse events and severity during Vedolizumab infusions and during all the follow up.
Measured: 48 weeks
Plasma viral load rebound or remision after interrupting Vedolizumab infusions and ART
Quantitative plasma viral load (Roche HIV-1 RNA Viral Load Assay) measured before and after interrupting Vedolizumab infusions and ART.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- HIV-infected subjects with no previous ART will begin ART together with Vedolizumab infusions at week 0, 4, 8, 12, 16, 20 and 24 weeks. At this time point ART and Vedolizumab treatment will be interrupted. Patients will be followed up until week 48. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increases above 10e5 HIV-RNA copies/mL (two consecutive measurements).
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, Luis F. Lopez-Cortes, Hospitales Universitarios Virgen del Rocío
- Investigators
- Ezequiel Ruiz-Mateos, PhD, Principal investigator, Virgen del Rocio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577782
- Sponsor's protocol ID
- FIS-VED-2017-01
- Other IDs
- 2018-000497-30, 2018
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pernas M, Tarancon-Diez L, Rodriguez-Gallego E, Gomez J, Prado JG, Casado C, Dominguez-Molina B, Olivares I, Coiras M, Leon A, Rodriguez C, Benito JM, Rallon N, Plana M, Martinez-Madrid O, Dapena M, Iribarren JA, Del Romero J, Garcia F, Alcami J, Munoz-Fernandez M, Vidal F, Leal M, Lopez-Galindez C, Ruiz-Mateos E. Factors Leading to the Loss of Natural Elite Control of HIV-1 Infection. J Virol. 2018 Feb 12;92(5):e01805-17. doi: 10.1128/JVI.01805-17. Print 2018 Mar 1.
PubMed 29212942Cicala C, Martinelli E, McNally JP, Goode DJ, Gopaul R, Hiatt J, Jelicic K, Kottilil S, Macleod K, O'Shea A, Patel N, Van Ryk D, Wei D, Pascuccio M, Yi L, McKinnon L, Izulla P, Kimani J, Kaul R, Fauci AS, Arthos J. The integrin alpha4beta7 forms a complex with cell-surface CD4 and defines a T-cell subset that is highly susceptible to infection by HIV-1. Proc Natl Acad Sci U S A. 2009 Dec 8;106(49):20877-82. doi: 10.1073/pnas.0911796106. Epub 2009 Nov 20.
PubMed 19933330Arthos J, Cicala C, Martinelli E, Macleod K, Van Ryk D, Wei D, Xiao Z, Veenstra TD, Conrad TP, Lempicki RA, McLaughlin S, Pascuccio M, Gopaul R, McNally J, Cruz CC, Censoplano N, Chung E, Reitano KN, Kottilil S, Goode DJ, Fauci AS. HIV-1 envelope protein binds to and signals through integrin alpha4beta7, the gut mucosal homing receptor for peripheral T cells. Nat Immunol. 2008 Mar;9(3):301-9. doi: 10.1038/ni1566. Epub 2008 Feb 10.
PubMed 18264102Guzzo C, Ichikawa D, Park C, Phillips D, Liu Q, Zhang P, Kwon A, Miao H, Lu J, Rehm C, Arthos J, Cicala C, Cohen MS, Fauci AS, Kehrl JH, Lusso P. Virion incorporation of integrin alpha4beta7 facilitates HIV-1 infection and intestinal homing. Sci Immunol. 2017 May 12;2(11):eaam7341. doi: 10.1126/sciimmunol.aam7341.
PubMed 28763793Byrareddy SN, Kallam B, Arthos J, Cicala C, Nawaz F, Hiatt J, Kersh EN, McNicholl JM, Hanson D, Reimann KA, Brameier M, Walter L, Rogers K, Mayne AE, Dunbar P, Villinger T, Little D, Parslow TG, Santangelo PJ, Villinger F, Fauci AS, Ansari AA. Targeting alpha4beta7 integrin reduces mucosal transmission of simian immunodeficiency virus and protects gut-associated lymphoid tissue from infection. Nat Med. 2014 Dec;20(12):1397-400. doi: 10.1038/nm.3715. Epub 2014 Nov 24.
PubMed 25419708Byrareddy SN, Arthos J, Cicala C, Villinger F, Ortiz KT, Little D, Sidell N, Kane MA, Yu J, Jones JW, Santangelo PJ, Zurla C, McKinnon LR, Arnold KB, Woody CE, Walter L, Roos C, Noll A, Van Ryk D, Jelicic K, Cimbro R, Gumber S, Reid MD, Adsay V, Amancha PK, Mayne AE, Parslow TG, Fauci AS, Ansari AA. Sustained virologic control in SIV+ macaques after antiretroviral and alpha4beta7 antibody therapy. Science. 2016 Oct 14;354(6309):197-202. doi: 10.1126/science.aag1276.
PubMed 27738167Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
PubMed 23964932Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
PubMed 23964933Jimenez-Leon MR, Gasca-Capote C, Roca-Oporto C, Espinosa N, Sobrino S, Fontillon-Alberdi M, Gao C, Roseto I, Gladkov G, Rivas-Jeremias I, Neukam K, Sanchez-Hernandez JG, Rigo-Bonnin R, Cervera-Barajas AJ, Mesones R, Garcia F, Alvarez-Rios AI, Bachiller S, Vitalle J, Perez-Gomez A, Camacho-Sojo MI, Gallego I, Brander C, McGowan I, Mothe B, Viciana P, Yu X, Lichterfeld M, Lopez-Cortes LF, Ruiz-Mateos E. Vedolizumab and ART in recent HIV-1 infection unveil the role of alpha4beta7 in reservoir size. JCI Insight. 2024 Jul 9;9(16):e182312. doi: 10.1172/jci.insight.182312.
PubMed 38980725
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03577782
- Acronym / sponsor ID
- FIS-VED-2017-01
- Conditions
- HIV Infections
- Keywords
- HIV, CD4+, T-cell, Reservoir, Cure, Antiretroviral therapy, Vedolizumab, Gut
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- Sep 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
HIV cannot be eliminated and remains in the body despite the treatment that is used for HIV-infection called antiretroviral treatment (ART). Individuals undergoing ART interruption rapidly experience virus rebound in the blood. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the elimination of the virus in blood in the absence of ART. New drugs associated to ART that allow the elimination of the virus in the blood after ART withdrawn are needed. In monkeys infected with SIV, the analog of HIV, the virus has disappeared from the blood after administration of a compound and cessation of ART. There is an equivalent compound in humans called Vedolizumab. The aim of the present study is to research if Vedolizumab combined with ART, in subjects without previous ART, is able to eliminate the virus from the blood after ART is not taken.
Detailed description
HIV cannot be eradicated and keep latent in anatomical and cellular reservoirs. In fact, patients undergoing antiretroviral treatment (ART) interruption rapidly experience plasma viral load rebound. The current alternative therapeutic strategies to antiretroviral treatment have the aim to achieve the eradication or permanent remission of plasma viral load, also known as functional cure, in the absence of ART, as occurs in persistent HIV controllers. In this scenario, new drugs associated to ART that allow the achievement of permanent plasma viral remission after ART withdrawn are needed.
The main targets of HIV infection are the memory CD4+ T-cells. This cell subset is mainly located in gut associated lymphoid tissue (GALT). These lymphocytes are recruited to the gut thanks to the expression of the integrin α4β7. The Env protein gp120 binds to α4β7 and enable the dissemination of HIV in the gut. At the same time the envelope of HIV is enriched in α4β7 coming from the plasma membrane of the host cells favoring its pathogenicity. Recently, the administration of a monoclonal antibody against α4β7 was shown to achieve significant protection for HIV transmission before and after low dose intravaginal inoculation of SIV in Rhesus Macaques. Surprisingly, long-term virological protection has been documented in SIV-infected macaques after ART interruption after administration and withdrawal of the monoclonal antibody against α4β7. The mechanisms through which this antibody has achieved the permanent remission of plasma viral load are not fully understood. The success of these findings in the simian model makes the antibody against α4β7 a good candidate as ART adjuvant with the aim to reach a functional cure and/or persistent virological remission in humans. Currently, there is a monoclonal antibody against α4β7 with known safety and security profiles in humans, this antibody is commercially available under the name of Vedolizumab. This antibody is used for the treatment of ulcerative colitis and Crohn Disease. In fact, there are already two clinical trials that are using Vedolizumab in HIV-infected patients (NCT02788175 y NCT03147859). In these clinical trials Vedolizumab is administered in the chronic phase of the infection in subjects with undetectable viral load during at least two years on ART. There are not clinical trials administering Vedolizumab in early stages of infection in naïve HIV-infected subjects for ART. Potentially, this strategy of early antibody treatment may increase the success of the therapy and decrease the time on ART of the individuals. The aim of the present clinical trial is to evaluate the safety and efficacy of Vedolizumab combined with ART to achieve permanent virological remission in naïve HIV-infected individuals after ART interruption.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- HIV-infected subjects with no previous ART will begin ART together with Vedolizumab infusions at week 0, 4, 8, 12, 16, 20 and 24 weeks. At this time point ART and Vedolizumab treatment will be interrupted. Patients will be followed up until week 48. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increases above 10e5 HIV-RNA copies/mL (two consecutive measurements).
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Biological: Entyvio (Vedolizumab)HIV-infected subjects with no previous ART will begin ART together with Vedolizumab infusions at week 0, 4, 8, 12, 16, 20 and 24 weeks. At this time point ART and Vedolizumab treatment will be interrupted. Patients will be followed up until week 48. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals with documented HIV-infection. Aged, 18 - 65 years.
- HIV-RNA >1x10e4 copies/mL.
- CD4+ T-cell counts >350 cells//μL
- To accept analytical ART interruption.
Key exclusion criteria (14 listed)
- Presence of major resistance mutations to the antiretrovirals used.
- Active opportunistic infections.
- Pregnancy or breastfeeding
- Active hepatitis C or B virus infection.
- Active or latent tuberculosis not treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entyvio (Vedolizumab)1. Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks. 2. Entyvio (Vedolizumab) (300mg), 7 intravenous infusions at week 0 (baseline) (concomitant with ART onset), 4, 8, 12, 16, 20 and 24. At week 24 ART and Vedolizumab administration will be interrupted. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements). Patients will be followed up until week 48. | Biological | Single group |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 48 weeks
The number of adverse events and severity during Vedolizumab infusions and during all the follow up.
Plasma viral load rebound or remision after interrupting Vedolizumab infusions and ART
Time frame: 48 weeks
Quantitative plasma viral load (Roche HIV-1 RNA Viral Load Assay) measured before and after interrupting Vedolizumab infusions and ART.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 29212942Pernas M, Tarancon-Diez L, Rodriguez-Gallego E, Gomez J, Prado JG, Casado C, Dominguez-Molina B, Olivares I, Coiras M, Leon A, Rodriguez C, Benito JM, Rallon N, Plana M, Martinez-Madrid O, Dapena M, Iribarren JA, Del Romero J, Garcia F, Alcami J, Munoz-Fernandez M, Vidal F, Leal M, Lopez-Galindez C, Ruiz-Mateos E. Factors Leading to the Loss of Natural Elite Control of HIV-1 Infection. J Virol. 2018 Feb 12;92(5):e01805-17. doi: 10.1128/JVI.01805-17. Print 2018 Mar 1.
- Background: PubMed 19933330Cicala C, Martinelli E, McNally JP, Goode DJ, Gopaul R, Hiatt J, Jelicic K, Kottilil S, Macleod K, O'Shea A, Patel N, Van Ryk D, Wei D, Pascuccio M, Yi L, McKinnon L, Izulla P, Kimani J, Kaul R, Fauci AS, Arthos J. The integrin alpha4beta7 forms a complex with cell-surface CD4 and defines a T-cell subset that is highly susceptible to infection by HIV-1. Proc Natl Acad Sci U S A. 2009 Dec 8;106(49):20877-82. doi: 10.1073/pnas.0911796106. Epub 2009 Nov 20.
- Background: PubMed 18264102Arthos J, Cicala C, Martinelli E, Macleod K, Van Ryk D, Wei D, Xiao Z, Veenstra TD, Conrad TP, Lempicki RA, McLaughlin S, Pascuccio M, Gopaul R, McNally J, Cruz CC, Censoplano N, Chung E, Reitano KN, Kottilil S, Goode DJ, Fauci AS. HIV-1 envelope protein binds to and signals through integrin alpha4beta7, the gut mucosal homing receptor for peripheral T cells. Nat Immunol. 2008 Mar;9(3):301-9. doi: 10.1038/ni1566. Epub 2008 Feb 10.
- Background: PubMed 28763793Guzzo C, Ichikawa D, Park C, Phillips D, Liu Q, Zhang P, Kwon A, Miao H, Lu J, Rehm C, Arthos J, Cicala C, Cohen MS, Fauci AS, Kehrl JH, Lusso P. Virion incorporation of integrin alpha4beta7 facilitates HIV-1 infection and intestinal homing. Sci Immunol. 2017 May 12;2(11):eaam7341. doi: 10.1126/sciimmunol.aam7341.
- Background: PubMed 25419708Byrareddy SN, Kallam B, Arthos J, Cicala C, Nawaz F, Hiatt J, Kersh EN, McNicholl JM, Hanson D, Reimann KA, Brameier M, Walter L, Rogers K, Mayne AE, Dunbar P, Villinger T, Little D, Parslow TG, Santangelo PJ, Villinger F, Fauci AS, Ansari AA. Targeting alpha4beta7 integrin reduces mucosal transmission of simian immunodeficiency virus and protects gut-associated lymphoid tissue from infection. Nat Med. 2014 Dec;20(12):1397-400. doi: 10.1038/nm.3715. Epub 2014 Nov 24.
- Background: PubMed 27738167Byrareddy SN, Arthos J, Cicala C, Villinger F, Ortiz KT, Little D, Sidell N, Kane MA, Yu J, Jones JW, Santangelo PJ, Zurla C, McKinnon LR, Arnold KB, Woody CE, Walter L, Roos C, Noll A, Van Ryk D, Jelicic K, Cimbro R, Gumber S, Reid MD, Adsay V, Amancha PK, Mayne AE, Parslow TG, Fauci AS, Ansari AA. Sustained virologic control in SIV+ macaques after antiretroviral and alpha4beta7 antibody therapy. Science. 2016 Oct 14;354(6309):197-202. doi: 10.1126/science.aag1276.
- Background: PubMed 23964932Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
- Background: PubMed 23964933Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739.
- Derived from this study: PubMed 38980725Jimenez-Leon MR, Gasca-Capote C, Roca-Oporto C, Espinosa N, Sobrino S, Fontillon-Alberdi M, Gao C, Roseto I, Gladkov G, Rivas-Jeremias I, Neukam K, Sanchez-Hernandez JG, Rigo-Bonnin R, Cervera-Barajas AJ, Mesones R, Garcia F, Alvarez-Rios AI, Bachiller S, Vitalle J, Perez-Gomez A, Camacho-Sojo MI, Gallego I, Brander C, McGowan I, Mothe B, Viciana P, Yu X, Lichterfeld M, Lopez-Cortes LF, Ruiz-Mateos E. Vedolizumab and ART in recent HIV-1 infection unveil the role of alpha4beta7 in reservoir size. JCI Insight. 2024 Jul 9;9(16):e182312. doi: 10.1172/jci.insight.182312.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ezequiel Ruiz-Mateos, PhD principal investigator
Virgen del Rocio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Entyvio (Vedolizumab) in people with HIV Infections, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ezequiel Ruiz-Mateos, PhD (+34955923109, ezequiel.ruizmateos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 (time frame: 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577782, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.