Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection (HAVARTI)
HIV-infection/AIDS
About this trial
This is an interventional treatment trial for HIV-infection/AIDS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The Ottawa Hospital -General CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
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
* 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.
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.
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.