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Vedolizumab for HIV/AIDS (HAVARTI Trial)
Phase 2
Recruiting
Led By Bill Cameron, MD
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months vedolizumab treatments, serial assessments over 12 months
Awards & highlights
HAVARTI Trial Summary
This trial is testing whether a drug called 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.
Who is the study for?
Adults aged 18-65 with HIV, on ART for 2-9 years with low viral loads, and good immune cell counts. They must understand the study and agree to participate. Excluded are those with other serious health issues, drug-resistant HIV, hepatitis B or C, untreated TB, pregnant or breastfeeding women, or those not using contraception.Check my eligibility
What is being tested?
The trial is testing if Vedolizumab can control HIV in the blood without ART after stopping it. Participants will receive Vedolizumab infusions every 2-4 weeks until week 20 and stop taking ART between weeks 6 and 7. Their health will be monitored up to a year.See study design
What are the potential side effects?
While specific side effects of Vedolizumab in this context aren't listed here, generally it may cause common infusion-related reactions like headache or skin rash; also potential risk of infections due to its immune-modulating effects.
HAVARTI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months vedolizumab treatments, serial assessments over 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months vedolizumab treatments, serial assessments over 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Vedolizumab safety and tolerance
Secondary outcome measures
PVL rebound and remission after ATI on vedolizumab treatment, and after discontinuation of vedolizumab.
PVL sustained rebound after ATI, and re-suppression on ART.
Side effects data
From 2020 Phase 4 trial • 278 Patients • NCT030291433%
Colitis ulcerative
3%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lead-in Period
Lead-in Failure Follow-up Period
RTP: Standard Treatment Arm
RTP: VDZ Dose Optimization: Regimen A
RTP: VDZ Dose Optimization: Regimen B
HAVARTI Trial Design
3Treatment groups
Experimental Treatment
Group I: Group C-600mg dose of vedolizumab per infusion followed by ATI - High DoseExperimental Treatment1 Intervention
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.
Group II: Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid DoseExperimental Treatment1 Intervention
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 III: Group A-150mg dose of vedolizumab per infusion followed by ATI - Low DoseExperimental Treatment1 Intervention
* 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.
Find a Location
Who is running the clinical trial?
CHEO Research InstituteUNKNOWN
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Ottawa Hospital Research InstituteLead Sponsor
561 Previous Clinical Trials
2,785,681 Total Patients Enrolled
Nebraska Centre for Substance Abuse ResearchUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious health condition that may affect your ability to participate in the study.You are an adult between the ages of 18 and 65 who has HIV infection.
Research Study Groups:
This trial has the following groups:- Group 1: Group C-600mg dose of vedolizumab per infusion followed by ATI - High Dose
- Group 2: Group A-150mg dose of vedolizumab per infusion followed by ATI - Low Dose
- Group 3: Group B-300mg dose of vedolizumab per infusion followed by ATI - Mid Dose
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any openings for participation in this experiment?
"Clinicaltrials.gov states that this trial is no longer actively searching for participants, having been first posted November 1st 2017 and last updated February 8th 2021. However, there are 1176 other trials currently in need of volunteers right now."
Answered by AI
Does this clinical trial represent a pioneering approach to treatment?
"Since 2015, Takeda has sponsored the exploration of Vedolizumab (brand name Entyvio), beginning with a 260-patient trial. After its Phase 4 drug approval was granted, over 20 ongoing trials have been conducted in 198 cities and 27 nations."
Answered by AI
Is this clinical investigation including participants who are octogenarians?
"According to the specified parameters, adults aged 18 and older but younger than 65 are eligible for this medical trial."
Answered by AI
Has the FDA sanctioned Vedolizumab (Entyvio) for public use?
"The safety of Vedolizumab (Entyvio) was subjectively assessed as a 2, since the drug is only in its second phase of testing and there are no reports confirming efficacy."
Answered by AI
What is the aggregate count of participants involved in this research?
"Unfortunately, applicants are not currently being accepted for this trial. The data posted on clinicaltrials.gov indicates that the initial posting was made on November 1st 2017 and the last edit was done on February 8th 2021. For those interested in other studies, there are presently 1155 HIV/AIDS trials actively recruiting as well as 21 Vedolizumab (Entyvio) related medical studies looking to enroll patients."
Answered by AI
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