Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection
HAVARTI
1 other identifier
interventional
10
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2017
CompletedFirst Posted
Study publicly available on registry
May 10, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMay 11, 2023
May 1, 2023
6.2 years
April 3, 2017
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
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.
serial phlebotomy measures over 12 months
PVL sustained rebound after ATI, and re-suppression on ART.
serial phlebotomy measures over 12 months
Study Arms (3)
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.
Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose
EXPERIMENTALThe 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
EXPERIMENTALThe 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.
Interventions
IV infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Cheo Research Institutecollaborator
- Nebraska Centre for Substance Abuse Researchcollaborator
Study Sites (1)
The Ottawa Hospital -General Campus
Ottawa, Ontario, K1H 8L6, Canada
Related Publications (2)
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.
PMID: 41323021DERIVEDMcGuinty 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.
PMID: 33033101DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bill Cameron, MD
Ottawa Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2017
First Posted
May 10, 2017
Study Start
November 1, 2017
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
May 11, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will share
Study dataset, after study closure and publication, by request.