NCT03147859: HAVARTI

Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection

Status unknown Phase 2 Last updated 11 May 2023

What this trial tests

Phase 2 trial testing Vedolizumab (brand name Entyvio) in HIV-infection/AIDS in 10 participants. Status unknown.

Timeline

1 November 2017

Primary endpoint
31 December 2023

31 December 2023

Quick facts

Lead sponsor	Ottawa Hospital Research Institute
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 November 2017
Primary completion	31 December 2023
Estimated completion	31 December 2023
Sites	1 location across Canada

Drugs / interventions tested

• Vedolizumab (brand name Entyvio) — full drug profile →

Conditions studied

• HIV-infection/AIDS — all drugs for HIV-infection/AIDS →

Sponsor

Ottawa Hospital Research Institute

Who can join

Adults 18 to 65, any sex, with HIV-infection/AIDS. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Barriers and strategies to achieve a cure for HIV.
   Pitman MC, Lau JSY, McMahon JH, Lewin SR. · · 2018 · cited 99× · PMID 29893245 · DOI 10.1016/s2352-3018(18)30039-0
2. The Incorporation of Host Proteins into the External HIV-1 Envelope.
   Burnie J, Guzzo C. · · 2019 · cited 56× · PMID 30669528 · DOI 10.3390/v11010085
3. Impact of Myeloid Reservoirs in HIV Cure Trials.
   Mitchell BI, Laws EI, Ndhlovu LC. · · 2019 · cited 28× · PMID 30835045 · DOI 10.1007/s11904-019-00438-5
4. Nose to brain delivery of antiretroviral drugs in the treatment of neuroAIDS.
   Sarma A, Das MK. · · 2020 · cited 15× · PMID 34765998 · DOI 10.1186/s43556-020-00019-8
5. Vedolizumab-mediated integrin α4β7 blockade does not control HIV-1SF162 rebound after combination antiretroviral therapy interruption in humanized mice.
   Ling L, Wu T, To KKW, Cheung KW, et al · · 2019 · cited 8× · PMID 30829743 · DOI 10.1097/qad.0000000000002149
6. Progress in achieving long-term HIV remission.
   Pino M, Paiardini M, Marconi VC. · · 2018 · cited 7× · PMID 29889662 · DOI 10.1097/coh.0000000000000487
7. Employing Broadly Neutralizing Antibodies as a Human Immunodeficiency Virus Prophylactic & Therapeutic Application.
   Ding C, Patel D, Ma Y, Mann JFS, et al · · 2021 · cited 5× · PMID 34354709 · DOI 10.3389/fimmu.2021.697683
8. 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.
   McGuinty M, Angel JB, Cooper CL, Cowan J, et al · · 2020 · cited 2× · PMID 33033101 · DOI 10.1136/bmjopen-2020-041359