Study Name
An Exploratory, Open-Label Study of Vedolizumab in Subjects with HIV Infection Undergoing Analytical Treatment Interruption
Study Number
16-I-0118
Goal of Study
The National Institutes of Health (NIH) is conducting a research study for people with HIV on HIV medications. In most people infected with HIV, their immune system can't control or cure the infection. Combination antiretroviral therapy ('cART'—a combination of anti-HIV drugs taken daily) can keep the amount of HIV virus very low for a long time. However, if treatment is stopped, the immune system isn't able to control the infection, and HIV levels go up again. People who take cART can also develop resistance to the medications or have permanent side effects.
The main purpose of this study is to see if the drug vedolizumab is safe and if it can control the amount of HIV in your blood when you are not taking your cART. Vedolizumab is currently FDA-approved for use in people with ulcerative colitis or Crohn's disease, under the trade name Entyvio. We do not know if it will be effective for controlling HIV, so its use in this study is experimental. Levels of HIV, CD4 cells (the 'good' immune cells that are damaged by HIV), and other measures of HIV infection will be monitored after you receive this product and have stopped taking your cART.
Study Regimen
A total of 15 individuals between the ages of 18-65 are expected to participate in this study. To be in the study, you must be willing to stop your HIV medications for up to 28 weeks and to practice safer sex. You will have nine infusions of vedolizumab over the course of the study, and stop your HIV medications after infusion seven. You will be seen every two weeks while you are off HIV medications and then monthly for six months after you re-start cART. The study will last about one year. Study procedures include physical exams, blood and plasma collection, vital signs, urinalysis, and infusions of vedolizumab. Volunteers will be compensated.
Eligibility Criteria
- You are HIV-1 positive and 18-65 years old.
- You have taken HIV medications continuously for at least two years.
- You have a CD4 (t-cell) count of 450 or more at screening.
- You have had an undetectable HIV viral load for at least two years.
- Your CD4 (t-cell) count has never been <200.
- You do not have active hepatitis.
- You do not have a history of heart problems or tuberculosis.
- If female, you are not currently pregnant or breast feeding.