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.

Contact Information

Volunteer or get more information:

Office of Patient Recruitment
Toll Free: 1-800-411-1222
TTY: 1-866-411-1010
Se habla español.
Email: prpl@mail.cc.nih.gov

Participating in Research

Watch a series of short informational videos about participating in clinical trials. These videos are intended to help potential participants understand how research works, what questions they should consider asking, and things to think about when deciding whether or not to participate in a study.

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