For Potential Participants

CURRENTLY ENROLLING

BEAT-HIV Delaney Collaboratory to Cure HIV-1 Infection by Combination Immunotherapy (Luis J. Montaner and James L. Riley, Principal Investigators)

The inability of antiretroviral therapy (ART) to clear HIV infection, and the observation that a sterilizing cure and/or stable remission can be achieved by a subset of ART-treated persons has galvanized the interest to advance clinical strategies towards a cure and/or stable remission.  Here, we build on clinical preliminary data from several single agent immunotherapy human trials that indicate a potential to inhibit HIV beyond ART.  Including scientists from 8 institutions and 4 industry partners, the BEAT-HIV Delaney Collaboratory will seek to develop and test innovative combined immunotherapy strategies to eradicate and/or permanently suppress HIV into remission in the absence of ART.

Please refer to clinicaltrials.gov for more information, NCT03588715.

Contact:

Ken Lynn, RN, Penn Presbyterian Medical Center: 215-662-8217 / kenneth.lynn@uphs.upenn.edu

Philadelphia FIGHT Research Staff: 215-525-8695

CURRENTLY ENROLLING

Engineering T Cells to Provide Durable Control of HIV-1 Replication (James L. Riley, Principal Investigator)

Current HIV-1 therapy (HAART) can control but not cure HIV-1 infection. The overarching scientific theme of this Program is to discover and apply novel approaches and state-of-the-art technologies to protect, direct, and sustain anti-HIV CD4+ T cell responses that can obviate the need for lifelong HAART in HIV-infected patients. Project 1: A Phase I Study Of C34-CXCR4 Modified CD4 T Cells In HIV-1 Infected Individuals Project Leader (PL): Pablo Tebas DESCRIPTION (as provided by applicant): In collaboration with Sangamo, we have previously employed the use of zinc finger nucleases (ZFN) to edit the CCR5 gene to generate HIV resistant CD4+ T cells. Building upon that success, and mindful of it limitations, our study aims to protect CD4 cells by expressing C34- CXCR4 to render them resistant to both R5 and X4 HIV. The hypothesis of our study is that autologous CD4+ T cells genetically modified with an HR2, C34-peptide conjugated to the CXCR4 N-terminus using lentiviral vector will be resistant to HIV infection in vivo in the setting of an analytical treatment interruption and will preserve and enhance an immunological response to HIV. In close collaboration with Projects 2, 3 and 4, and Cores A and B, we will evaluate in vivo C34- CXCR4-modified autologous CD4+T cells with 3 Specific Aims SA1: Complete pre-clinical testing necessary to support manufacturing of C34-CXCR4-modified autologous CD4+T cells. SA2: Conduct a proof of concept clinical trial to determine the safety of C34-CXCR4-modified autologous CD4+T cells in patients with well controlled viral replication. SA3: Evaluate the host and virological response to C34-CXCR4-modified autologous CD4+T cells.

Please refer to clinicaltrials.gov for more information, NCT03617198.

Contact:

Eileen Donaghy, CRNP, University of Pennsylvania: 215-349-8092

ENROLLING BY INVITATION

Home-based Viral Load Testing Device

BEAT-HIV investigators are partnering with Merck, Inc. and Tasso, Inc. to assess the reliability and acceptability of a home-based viral load testing device. The micro-blood collection device is currently being tested with participants enrolled in each of the two BEAT-HIV clinical trials that are currently recruiting volunteers. At this time, the home-based viral load testing device is not available to anyone who is not enrolled in the BEAT-HIV clinical trials.

HIV cure-directed clinical trials often include an analytic treatment interruption (ATI) – see Position Paper on BEAT-HIV home page. ATIs require frequent clinic visits to monitor participants’ viral load in order to stay within study safety guidelines. The COVID epidemic has changed the research landscape, including a stated desire among study participants and community advocates to reduce the number of study visits (and potential exposure to COVID-19 during transit and potential at the clinic).

The device being tested could potentially reduce the number of required clinic visits for blood collection, but only if the home-based viral load device test works as well as standard lab-based viral load testing that can now only be done at the clinic. Just as important is to determine how people living with HIV feel about the device and the process for returning it to the lab by mail or courier, how comfortable they are with using the home-based device, and if they have any other concerns.

CURRENTLY ENROLLING

Innate Immunity and Immunopathogenesis

As a part of investigating the mechanism of disease, HIV infection impact on immune function, testing concepts for future study as HIV cure strategies, and immune recovery after ART, researchers at the Wistar Institute, in association with Philadelphia FIGHT and the University of Pennsylvania, are collecting peripheral blood in order to establish a repository of persons living with HIV that can donate blood. Donated blood will be archived and used in HIV immune research.

Contact:

Ken Lynn, RN, Penn Presbyterian Medical Center: 215-662-8217 / kelynn@pennmedicine.upenn.edu

Philadelphia FIGHT Research Staff: 215-525-8695 / research@fight.org

ENROLLMENT COMPLETE

BEAT-HIV Study – Beyond Antiretroviral Treatment: Reducing Proviral HIV DNA with Interferon Immunotherapy (Luis Montaner, Principal Investigator)

The identification and characterization of innovative strategies to reduce integrated HIV-1 DNA by harnessing host-mediated mechanisms are paramount to achieving eradication of HIV-1 without continued ART. This project pursues a strategy already observed to induce reductions in integrated HIV DNA by now reconfirming this activity while: a) determining impact on tissue levels, and b) obtaining added insights as to how it works.

For more information, go to ClinicalTrials.gov.

Contact:

Ken Lynn, RN, Penn Presbyterian Medical Center: 215-662-8217 / kenneth.lynn@uphs.upenn.edu

Philadelphia FIGHT Research Staff: 215-525-8695  / research@fight.org