Study Name
Combination Therapy with 3BNC117 and 10-1074 in HIV-Infected Individuals
Study Number
18-I-0115
Goal of Study
The NIH is conducting a research study for people living with HIV. The objective of the study is to see if the experimental products 3BNC117 and 10-1074 are safe and can control HIV levels in the blood of people who are not taking antiretroviral therapy (ART), or in people who stop taking their ART during the study. 3BNC117 and 10-1074 are experimental products that are not approved by the Food and Drug Administration (FDA).
Study Regimen
A total of 30 individuals 18-65 years old are expected to participate in this study. Participants will be people living with HIV who are either on ART, and willing to stop treatment for at least 28 weeks; or not taking ART, with low levels of HIV in the blood. Participants will be screened with a physical exam, medical history, and blood, heart, and urine tests. Participants will get the 2 study products or salt water (placebo). A thin tube will be placed in an arm vein. Each product will be given directly into the vein for about one hour.
To help collect blood cells to study in the laboratory, participants may have a procedure known as leukapheresis in which blood will be removed through a needle in the arm. Some of the white blood cells will be separated from the blood and used for research studies to see how 3BNC117 and 10-1074 effects HIV and the immune system. The rest of the blood will be returned to the person through another needle in the arm.
Participants will have 18 study visits over 28 weeks. They will repeat some screening tests, and may have leukapheresis again. At eight study visits, participants will get the study products or placebo.
All participants will be followed for at least 24 weeks after their last dose of the study infusions. Participants who are in the group that stops ART will be monitored closely to make sure the levels of virus in their blood do not go too high. If at any time during this the study a person develops HIV-related symptoms, or if the viral levels go up to high levels for more than 4 weeks, ART will be restarted and no further infusions of 3BNC117 and 10-1074 will be given.
Eligibility Criteria
- You are at least 18-65 years old and living with HIV
- If you have been on continuous ART for at least one year, your CD4 t-cell count is >450, and your viral load has been <50 for at least one year; you must have started your ART within 12 weeks of your HIV diagnosis; you must be willing to stop your ART for up to 24 weeks
- If you have not been on ART for at least two years, your CD4 t-cell count is >450, and your viral load is between 200-5000
- You must be willing to receive either the study products or placebo, at random
- You are in good general health, and do not have hepatitis, heart problems, or cancer
- You do not have difficulty having blood drawn
- You do not abuse drugs or alcohol
- You have a primary care provider