Skip to content

Vedolizumab Treatment in Antiretroviral Drug Treated Chronic HIV Infection

HIV-infection/AIDS

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.

null

Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 65

Participation Criteria

Inclusion Criteria:

1. Adult (≥ 18 to 65 years) with HIV infection.
2. Nadir CD4 T cell count ≥ 200 and current CD4 T cell count \> 500 cells/mcL
3. Adherent on ART 2 to 9 years with sustained pVL ≤ 50 copies/mL
4. Ability to comprehend and provided informed consent

Exclusion Criteria:

1. Past AIDS-defining or AIDS-related immune deficiency diseases
2. Past drug-resistant HIV or ART-refractory pVL response
3. Current hepatitis B or C virus infection, or untreated latent TB infection
4. Clinically significant concurrent health condition.
5. Pregnancy, lactation, or non-adherence with contraception if fertile.

Study Location

The Ottawa Hospital -General Campus
The Ottawa Hospital -General Campus
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Donald W Cameron, MD

[email protected]
613-737-8923
Study Sponsored By
Ottawa Hospital Research Institute
Participants Required
More Information
Study ID: NCT03147859