HIV-infection/AIDSPhase 2HAVARTINCT03147859
Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection
A Phase 2 study testing Vedolizumab (brand name Entyvio) in people with HIV-infection/AIDS, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Background: In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot either control or eradicate the infection. There are good medicinal treatments, collectively called "ART" (antiretroviral therapy) which control HIV infection by suppressing the virus in the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV-infection/AIDS
- What is being tested?
- Vedolizumab (brand name Entyvio)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2017to 31 Dec 2023
- Phase
- Phase 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
- Adult (≥ 18 to 65 years) with HIV infection.
- Nadir CD4 T cell count ≥ 200 and current CD4 T cell count > 500 cells/mcL
- Adherent on ART 2 to 9 years with sustained pVL ≤ 50 copies/mL
- Ability to comprehend and provided informed consent
Who cannot join
- Past AIDS-defining or AIDS-related immune deficiency diseases
- Past drug-resistant HIV or ART-refractory pVL response
- Current hepatitis B or C virus infection, or untreated latent TB infection
- Clinically significant concurrent health condition.
- Pregnancy, lactation, or non-adherence with contraception if fertile.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital -General Campus
Ottawa, Ontario, K1H 8L6
Donald W Cameron, MD, 613-737-8923, bcameron@ohri.ca
Donald W Cameron, MD
About this study
Background:
In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot either control or eradicate the infection. There are good medicinal treatments, collectively called "ART" (antiretroviral therapy) which control HIV infection by suppressing the virus in the bloodstream. ART is needed for life, and if a person stops taking ART the HIV infection returns in the bloodstream. So, there is good treatment, but no cure. The researchers want to test whether a period of treatment with vedolizumab can be used to control HIV infection in the bloodstream in persons with HIV on ART, after stopping ART.
Read more
Objective:
To determine whether vedolizumab is safe and tolerable in people with HIV, to assess the safety of an analytical treatment interruption (ATI), and to determine whether vedolizumab can control HIV infection in the bloodstream without the use of ART.
Eligibility:
Adults 18-65 with HIV who are being treated with ART
Design:
Participants will be screened with: Physical exam, medical history, blood and urine tests Participants will have a baseline visit which will include repeat of the screening testing.
Participants will then present for their first study visit which will include: receiving vedolizumab infusions through an arm vein, repeats of the baseline testing. Participants will then have serial visits on a pre-specific schedule to receive ongoing vedolizumab doses every 2-4 weeks until week 20. Each visit will also include repeat of the baseline tests.
After week 6 and before week 7 patients will discontinue ART. After the final infusion of vedolizumab at week 20 patients will continue to be assessed with physical exam, medical history, and repeat of the baseline testing every 4 weeks up to 1 year.
ART will be re-started for participants if the level of HIV in the blood becomes too high, persists for too long, or if the CD4 count decreases by too much.
Read the detailed description
HIV is a chronic active infection of lymphocytes and monocytoid cells resulting in a progressive and profound depletion of T cell subsets and ultimately in acquired immune deficiency syndrome (AIDS). HIV infects cells of the immune system throughout the body and may cause an active cytolytic infection in activated lymphocytes, become dormant as a latent infection in resting lymphocytes, or continue as a chronically active infection in macrophages. Continuous anti-retroviral drug treatment (ART) suppresses virus within the bloodstream and allows some degree of immune healing so as to permit near-normal health and life expectancy. However, interruption of ART is uniformly followed by rebound of viremia as a result of ongoing chronic active infection, and reactivation of latent infection. Successful ART requires daily medications indefinitely. There is an ongoing need for treatments which are more effective in the eradication of HIV. Counter to past expectations for cell-mediated immunity, broadly neutralizing monoclonal antibodies (nmAb) have been developed which show anti-HIV activity in vivo in reducing viremia (plasma virus load, PVL), and in slightly reducing recurrence of lasting PVL following analytical treatment interruption (ATI). Monoclonal antibody therapies against host cellular markers such as HIV co-receptors have been put forward as potential strategy in immunological treatment of HIV infection. If activated lymphocytes could be protected from cytolytic HIV infection in the presence of concurrent active HIV infection of other cells and tissues, then unperturbed potent acquired specific or innate immunity might confer lasting immunological remission of HIV infection.
This year, an unexpected finding of sustained remission of plasma viremia level (PVL) to below quantifiable assay limits in a rhesus macaque SIV infection model of AIDS was reported. The envelope of SIV (and HIV) appears to interact with α4β7 integrin, a lymphocyte homing receptor for trafficking to gut mucosal-associated lymphoid tissue (GALT) that was the target of mAb treatment in this study. This study showed that in animals treated with the mAb while discontinuing ART there was a diminished rebound and sustained remission of PVL, and less GALT associated viral load for a long-lasting period of at least 24 months. The mechanism of this unexpected post-treatment effect is unknown. In humans infected with HIV, such an effect sustained over time with continued remission of progressive immunodeficiency would meet definitional criteria of "functional cure" of HIV/AIDS. The results observed in the SIV model reveal a promising avenue for investigation in this area of research towards control of HIV infection in absence of ART. We propose to assess the safety and tolerability of anti-α4β7 integrin monoclonal antibody in healthy HIV-infected adults on ART, to assess the safety of ATI and whether anti-α4β7 integrin monoclonal antibody treatment can induce sustained virologic remission in the absence of ART.
- Conditions
- HIV-infection/AIDS
- Being tested
- Vedolizumab (brand name Entyvio)
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vedolizumab (brand name Entyvio)Biological
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose | Experimental | * Please note that the previous low dose arm was 75mg of vedolizumab per infusion, but no participant was ever given this dose. The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 150 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 doses as tolerated. ATI will begin between weeks 6 and 7, and infusions continued at weeks 8, 12, 16 and 20. Receives: Biological: Vedolizumab (brand name Entyvio) |
| Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose | Experimental | The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 300 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response. Receives: Biological: Vedolizumab (brand name Entyvio) |
| Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose | Experimental | The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 600 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response. Receives: Biological: Vedolizumab (brand name Entyvio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vedolizumab safety and tolerance
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, with their timing of onset and resolution.
Measured: 6 months vedolizumab treatments, serial assessments over 12 months
Secondary outcomes (2)
PVL rebound and remission after ATI on vedolizumab treatment, and after discontinuation of vedolizumab.
Quantitative PVL (Abbott HIV1 Viral Load Assay) measured serially during and after ATI.
Measured: serial phlebotomy measures over 12 months
PVL sustained rebound after ATI, and re-suppression on ART.
Quantitative PVL (Abbott HIV1 Viral Load Assay) measured serially during and after ATI.
Measured: serial phlebotomy measures over 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Nov 2017
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV-infection/AIDSStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Cheo Research Institute, Nebraska Centre for Substance Abuse Research
- Responsible party
- Sponsor
- Investigators
- Bill Cameron, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147859
- Sponsor's protocol ID
- 20160928-01H
- Acronym
- HAVARTI
- Status last verified
- May 2023
- First submitted
- 3 Apr 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study dataset, after study closure and publication, by request.
Publications
Barros PO, Burke Schinkel SC, Nayak AL, Haas B, Berthoud TK, McGuinty M, Cameron DW, Angel JB. Failure of gammadelta T Cell Recovery in the Gut With Effective Anti-HIV Therapy. J Immunol Res. 2025 Nov 27;2025:9883892. doi: 10.1155/jimr/9883892. eCollection 2025.
PubMed 41323021McGuinty M, Angel JB, Cooper CL, Cowan J, MacPherson PA, Kumar A, Murthy S, Sy R, Dennehy M, Tremblay N, Byrareddy SN, Cameron DW. Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity. BMJ Open. 2020 Oct 8;10(10):e041359. doi: 10.1136/bmjopen-2020-041359.
PubMed 33033101
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection
- ClinicalTrials.gov ID
- NCT03147859
- Acronym / sponsor ID
- HAVARTI / 20160928-01H
- Conditions
- HIV-infection/AIDS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Cheo Research Institute, Nebraska Centre for Substance Abuse Research
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 10 May 2017 (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.
Background:
In nearly all people with human immunodeficiency virus (HIV) infection, immunity cannot either control or eradicate the infection. There are good medicinal treatments, collectively called "ART" (antiretroviral therapy) which control HIV infection by suppressing the virus in the bloodstream. ART is needed for life, and if a person stops taking ART the HIV infection returns in the bloodstream. So, there is good treatment, but no cure. The researchers want to test whether a period of treatment with vedolizumab can be used to control HIV infection in the bloodstream in persons with HIV on ART, after stopping ART.
Objective:
To determine whether vedolizumab is safe and tolerable in people with HIV, to assess the safety of an analytical treatment interruption (ATI), and to determine whether vedolizumab can control HIV infection in the bloodstream without the use of ART.
Eligibility:
Adults 18-65 with HIV who are being treated with ART
Design:
Participants will be screened with: Physical exam, medical history, blood and urine tests Participants will have a baseline visit which will include repeat of the screening testing.
Participants will then present for their first study visit which will include: receiving vedolizumab infusions through an arm vein, repeats of the baseline testing. Participants will then have serial visits on a pre-specific schedule to receive ongoing vedolizumab doses every 2-4 weeks until week 20. Each visit will also include repeat of the baseline tests.
After week 6 and before week 7 patients will discontinue ART. After the final infusion of vedolizumab at week 20 patients will continue to be assessed with physical exam, medical history, and repeat of the baseline testing every 4 weeks up to 1 year.
ART will be re-started for participants if the level of HIV in the blood becomes too high, persists for too long, or if the CD4 count decreases by too much.
Detailed description
HIV is a chronic active infection of lymphocytes and monocytoid cells resulting in a progressive and profound depletion of T cell subsets and ultimately in acquired immune deficiency syndrome (AIDS). HIV infects cells of the immune system throughout the body and may cause an active cytolytic infection in activated lymphocytes, become dormant as a latent infection in resting lymphocytes, or continue as a chronically active infection in macrophages. Continuous anti-retroviral drug treatment (ART) suppresses virus within the bloodstream and allows some degree of immune healing so as to permit near-normal health and life expectancy. However, interruption of ART is uniformly followed by rebound of viremia as a result of ongoing chronic active infection, and reactivation of latent infection. Successful ART requires daily medications indefinitely. There is an ongoing need for treatments which are more effective in the eradication of HIV. Counter to past expectations for cell-mediated immunity, broadly neutralizing monoclonal antibodies (nmAb) have been developed which show anti-HIV activity in vivo in reducing viremia (plasma virus load, PVL), and in slightly reducing recurrence of lasting PVL following analytical treatment interruption (ATI). Monoclonal antibody therapies against host cellular markers such as HIV co-receptors have been put forward as potential strategy in immunological treatment of HIV infection. If activated lymphocytes could be protected from cytolytic HIV infection in the presence of concurrent active HIV infection of other cells and tissues, then unperturbed potent acquired specific or innate immunity might confer lasting immunological remission of HIV infection.
This year, an unexpected finding of sustained remission of plasma viremia level (PVL) to below quantifiable assay limits in a rhesus macaque SIV infection model of AIDS was reported. The envelope of SIV (and HIV) appears to interact with α4β7 integrin, a lymphocyte homing receptor for trafficking to gut mucosal-associated lymphoid tissue (GALT) that was the target of mAb treatment in this study. This study showed that in animals treated with the mAb while discontinuing ART there was a diminished rebound and sustained remission of PVL, and less GALT associated viral load for a long-lasting period of at least 24 months. The mechanism of this unexpected post-treatment effect is unknown. In humans infected with HIV, such an effect sustained over time with continued remission of progressive immunodeficiency would meet definitional criteria of "functional cure" of HIV/AIDS. The results observed in the SIV model reveal a promising avenue for investigation in this area of research towards control of HIV infection in absence of ART. We propose to assess the safety and tolerability of anti-α4β7 integrin monoclonal antibody in healthy HIV-infected adults on ART, to assess the safety of ATI and whether anti-α4β7 integrin monoclonal antibody treatment can induce sustained virologic remission in the absence of ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose | Experimental | Biological: Vedolizumab (brand name Entyvio)* Please note that the previous low dose arm was 75mg of vedolizumab per infusion, but no participant was ever given this dose. The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 150 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 doses as tolerated. ATI will begin between weeks 6 and 7, and infusions continued at weeks 8, 12, 16 and 20. |
| Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose | Experimental | Biological: Vedolizumab (brand name Entyvio)The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 300 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response. |
| Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose | Experimental | Biological: Vedolizumab (brand name Entyvio)The study will have a 20-week treatment phase and a 28-week follow-up phase over one year. Intravenous infusion of 600 mg of vedolizumab per infusion per visit schedule will be administered to 4 participants. The visit schedule will be the same for each group - Infusion at weeks 0, 2, 5, 8 and every 4 weeks thereafter up to 40 weeks for at least 7 (and up to 12) doses as tolerated. ATI will begin between week 10, and infusions continued at weeks 12, 16 and 20. Infusions may also be given at weeks 24, 28, 32, 36 and 40 depending on tolerance and pVL response. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥ 18 to 65 years) with HIV infection.
- Nadir CD4 T cell count ≥ 200 and current CD4 T cell count > 500 cells/mcL
- Adherent on ART 2 to 9 years with sustained pVL ≤ 50 copies/mL
- Ability to comprehend and provided informed consent
Key exclusion criteria (5 listed)
- Past AIDS-defining or AIDS-related immune deficiency diseases
- Past drug-resistant HIV or ART-refractory pVL response
- Current hepatitis B or C virus infection, or untreated latent TB infection
- Clinically significant concurrent health condition.
- Pregnancy, lactation, or non-adherence with contraception if fertile.
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 |
|---|---|---|
| Vedolizumab (brand name Entyvio)IV infusion | Biological | Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose, Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose, Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose |
Primary outcome
Vedolizumab safety and tolerance
Time frame: 6 months vedolizumab treatments, serial assessments over 12 months
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, with their timing of onset and resolution.
2 secondary outcomes
PVL rebound and remission after ATI on vedolizumab treatment, and after discontinuation of vedolizumab.
Time frame: serial phlebotomy measures over 12 months
PVL sustained rebound after ATI, and re-suppression on ART.
Time frame: serial phlebotomy measures over 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Derived from this study: PubMed 41323021Barros PO, Burke Schinkel SC, Nayak AL, Haas B, Berthoud TK, McGuinty M, Cameron DW, Angel JB. Failure of gammadelta T Cell Recovery in the Gut With Effective Anti-HIV Therapy. J Immunol Res. 2025 Nov 27;2025:9883892. doi: 10.1155/jimr/9883892. eCollection 2025.
- Derived from this study: PubMed 33033101McGuinty M, Angel JB, Cooper CL, Cowan J, MacPherson PA, Kumar A, Murthy S, Sy R, Dennehy M, Tremblay N, Byrareddy SN, Cameron DW. Vedolizumab treatment across antiretroviral treatment interruption in chronic HIV infection: the HAVARTI protocol for a pilot dose-ranging clinical trial to assess safety, tolerance, immunological and virological activity. BMJ Open. 2020 Oct 8;10(10):e041359. doi: 10.1136/bmjopen-2020-041359.
- Individual participant dataSharing planned: Yes. Study dataset, after study closure and publication, by request.
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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.
Bill Cameron, MD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vedolizumab (brand name Entyvio) in people with HIV-infection/AIDS, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 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 11 May 2023. 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 Canada. 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 phase mean?
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 Bill Cameron, MD (613-737-8923, bcameron@toh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vedolizumab safety and tolerance (time frame: 6 months vedolizumab treatments, serial assessments over 12 months). 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 NCT03147859, which also lists 2 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 11 May 2023.