VRC-HIVMAB060-00-AB (VRC01) in People With Chronic HIV Infection Undergoing Analytical Treatment Interruption
Condition: HIV
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      - A combination of daily drugs (called cART) can keep human immunodeficiency virus (HIV) very
      low for a long time. But cART can lose effectiveness and cause permanent side effects. If
      treatment stops, HIV levels go up again. Researchers want to see if a new product can control
      HIV levels when a person is off cART.

      Objective:

      - To see if the new product VRC01 is safe and can control the HIV level in the blood when a
      person is not taking cART.

      Eligibility:

      - Adults ages 18-65 with HIV who are willing to interrupt their treatment for at least 24
      weeks.

      Design:

        -  Participants will be screened with:

        -  Physical exam

        -  Medical history

        -  Heart tests

        -  Blood and urine tests.

        -  Their HIV drugs may be switched. They will keep taking them until a few days after Visit
           1.

        -  Visit 1: Repeat screening procedures.

        -  Participants will also have genetic testing and leukapheresis. For this, blood will be
           removed through a needle in one arm and circulated through a machine that removes white
           blood cells. The rest of the blood is returned through a needle in the other arm.

        -  They will get the first study drug dose through a thin tube in an arm vein for about 1
           hour.

        -  For 24 weeks, participants will have 16 visits. They will have blood drawn every visit.
           At some visits they will repeat the screening procedures and get another VRC01 dose.
           They may have another leukapheresis.

        -  Four weeks after the last dose, participants will restart their cART. For 20 weeks, they
           will have monthly visits to repeat the screening procedures and discuss new symptoms.
    

Detailed description: 
      Recent advances in antibody cloning technologies have led to the discovery of a number of
      highly potent, HIV-specific, broadly neutralizing monoclonal antibodies from B cells of
      HIV-infected individuals. It has been shown that certain broadly neutralizing HIV-specific
      antibodies can prevent acquisition of the virus, suppress viral replication, delay and/or
      prevent plasma viral rebound following treatment interruption in Simian Immunodeficiency
      virus (SIV)-infected animals and block cell-to-cell transmission of laboratory-adapted HIV in
      vitro. However, it is unclear what in vivo effects these antibodies might have on plasma
      viral rebound in HIV-infected individuals following discontinuation of combination
      antiretroviral therapy (cART).

      In this regard, it has been shown that virtually all infected individuals who initiated cART
      during the chronic phase of infection experience plasma viral rebound upon cessation of
      therapy. Current research on the treatment of HIV-infected individuals has been heavily
      focused on developing strategies aimed at achieving sustained virologic remission in the
      absence of cART. Thus, it is of great interest to investigate whether a potent HIV-specific
      monoclonal antibody, such as VRC01, can prevent plasma viral rebound in infected individuals
      upon discontinuation of cART. We propose to examine the effect of VRC01 on plasma viral
      rebound in HIV-infected individuals following analytical treatment interruption (ATI).
    

Intervention name(s): VRC-HIVMAB060-00-AB (VRC01)
Intervention type(s): Biological
Intervention description(s): A potent HIV-specific monoclonal antibody
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Neutralizing Antibodies; HIV Therapy