Vedolizumab (Anti-alpha4beta7) in Subjects With HIV Infection Undergoing Analytical Treatment Interruption

Completed · Phase 1

Conditions studied: HIV

In brief

Background: In most people infected with human immunodeficiency virus (HIV), their immune system cannot control HIV infection. They need drugs called combination antiretroviral therapy (cART) to control the HIV. When people stop cART treatment, their immune system cannot control the infection again. They can also become resistant to cART and have lasting side effects. Researchers want to test if the drug vedolizumab is effective at controlling HIV infection without the need for cART. Objective: To test if vedolizumab is safe and can control the amount of HIV in the blood when cART is not taken. Eligibility: People ages 18-65 who have HIV and are being treated with cART Design: Participants will be screened with: Physical exam Medical history Electrocardiogram: Soft, sticky patches on the chest, arms, and legs measure heart activity. Blood and urine tests Participants will have a baseline visit. This will be 2-5 hours each day for 1-2 days. It will include repeats of the screening tests and: Leukapheresis: Blood is removed through a needle in the arm. A machine separates the white blood cells from the blood. The rest of the blood is returned to the participant. Neurologic exam: The nerves and reflexes are tested. First vedolizumab infusion through an arm vein Participants will have visits every 4 weeks for 30 weeks. These will include: Vedolizumab infusions Repeats of baseline tests Participants will have more visits for blood draws. Participants will keep taking cART until after the week 22 infusion. After discontinuing cART at study week 22, participants will be seen every two weeks to monitor the CD4 count and the level of HIV in the blood. Some of these visits will occur in between infusion visits and will only take about 1 hour to complete. cART will be restarted if a participant's HIV levels go up to high, or if their CD4 cell counts decreases by too much. For the follow-up phase, participants will have visits every 4 weeks for 24 weeks. These will include blood tests and a physical exam. ...

Key facts

Study ID

NCT02788175

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

26

Starts

2016-05-28

Expected to finish

2019-03-04

Last updated by the study team

2020-02-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Chronic hepatitis B, as evidenced by a positive test for hepatitis B surface antigen (HBsAg), or chronic hepatitis C virus (HCV) infection, as evidenced by a positive test for HCV RNA. Subjects with a positive test for HCV antibody and a negative test for HCV RNA are eligible.
• Documented nadir CD4+ T cell count <200 cells /mm3
• Documented multiclass antiretroviral drug resistance that, in the judgment of the investigator, would pose a risk of virologic failure should additional mutations develop during the study
• HIV immunotherapy or vaccine(s) received within 1 year prior to screening
• Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) received within 2 weeks prior to study enrollment
• Receipt of other investigational study agent within 28 days of enrollment
• Any active malignancy that may require systemic chemotherapy or radiation therapy
• Systemic immunosuppressive medications received within 3 months prior to enrollment. The following are not excluded: [1] corticosteroid nasal spray or inhaler; [2] topical corticosteroids for mild, uncomplicated dermatitis; and [3] oral/parenteral corticosteroids administered for non-chronic conditions not expected to recur (length of therapy less than or equal to 10 days, with completion in more than or equal to 30 days prior to enrollment)
• History or other clinical evidence of:
• Significant or unstable cardiac disease (e.g., angina, congestive heart failure, recent myocardial infarction)
• Severe illness, chronic liver disease, malignancy, immunodeficiency other than HIV, active systemic infection other than HIV, or any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study
• Active or latent tuberculosis, regardless of treatment history
• Neurologic or neuropsychiatric disorder, the symptoms of which mimic PML and could interfere with the assessment of safety (e.g. history of encephalitis with motor sequela, stroke with sequela, severe major depressive disorder, severe bipolar disorder, seizure disorder)
• Active drug or alcohol abuse or any other pattern of behavior that, in the opinion of the investigator, would interfere with adherence to study requirements
• Pregnancy or breast-feeding
• Co-enrollment Guidelines: Co-enrollment in other trials is restricted, other than enrollment on observational studies. Study staff should be notified of co-enrollment as it will require the approval of the Principal Investigator.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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