A Single arm Open Label Phase 2 trial of anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 (UB-421)

About the Study

The purpose of this study is: (1) to see if a drug called UB-421 is able to control human immunodeficiency virus (HIV) in patients with a virus that has become so resistant to anti-HIV drugs that an effective treatment regimen cannot be put together using drugs currently approved by the US Food and Drug Administration (FDA); and (2) to see if UB-421 is safe for patients with multiple-drug resistant HIV.

UB-421 is an experimental drug that can prevent the HIV virus from killing CD4 T cells in the laboratory. Preliminary studies in people living with HIV suggest that UB-421 can control HIV in people and may be effective in people living with HIV resistance to currently available anti-HIV drugs.

What does the study involve?

At the start of the Treatment Phase (Day 7) all subjects will receive weekly 5 mg/kg intravenous dose of UB-421 and continue their current failing therapy for another 2 weeks (Day 7 – 20). On Day 21, subjects will switch antiretroviral therapy (ART) to an optimized background therapy (OBT) regimen and continue receiving UB-421 at 5 mg/kg given every week for a 24-week maintenance period.

Is compensation provided?

There is no cost, and subjects will be compensated.

Who Can Participate

You can participate if:

• You are age 18 or older and living with HIV
• You have been on HIV medications continuously for at least six months, OR you have been taken off HIV medications in the past eight weeks due to failure
• You have a CD4 t-cell count > 350 and viral load is >1000
• You have documented resistance to at least one HIV medication
• You have a doctor you see regularly for HIV
• You do not have difficulty with blood draws
• You do not have chronic hepatitis B and/or chronic hepatitis C. YES
• If female, you are not pregnant, breastfeeding, or trying to become pregnant, and are willing to use effective contraception for the study duration
• If male and engaging in sexual activity that could lead to pregnancy, you must agree to use condoms while on study

Visit ClinicalTrials.gov for details.