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XTRA Study

University of North Carolina at Chapel Hill


Description

We are learning about the safety of combining a cell therapy (HXTC therapy) with regular doses of a drug called Vorinostat (VOR) as a possible approach for improving the strength of your immune system against HIV. In this study, we will collect your blood, remove the cells in your immune system that fight infection (T cells), and expose them to HIV proteins so that they will recognize the HIV virus again. These re-educated T cells are called HXTCs (HIV-specific T cells). In this study we will use HXTC therapy (putting your re-educated T cells back into your body to get your immune system to respond better against HIV) along with the drug VOR, which has been shown to stimulate your resting CD4 cells to become active and release the HIV virus. The purpose of this study is to: 1) Evaluate the safety of a series of HXTC infusions in combination with serial doses of VOR and 2) Help scientists evaluate ways of re-activating latent (non-active) HIV virus and determine if the immune system can be made stronger to eliminate the activated HIV virus.


Keywords:

HIV/AIDS


Category:

Drug or Biologic
Phase:1

Qualifications

 


Age
18 - 64 years


Gender
Any


Study Population

HIV-infected men and women between 18 and 64 years of age with durable viral suppression for greater than or equal to 24 months as measured on standard HIV RNA assays. Eligible participants must be on stable cART and have a CD4 cell count greater than or equal to 350 cells/mm3.


Investigator

David Margolis
Distinguished Professor
Medicine-Infectious Diseases

For questions, contact:

Maureen Furlong
search4thecure@med.unc.edu
(919) 445-2772
Visit Website

Recruitment Period End

December 31, 2019

Location

Primary Location
Clinical & Translational Research Center (CTRC)

Secondary Location
UNC Hospital Apheresis lab

Study Qualifications

Gender Any

Age Range 18 - 64 years

Participant qualification(s) Men and women between 18-64 years with HIV-1 who have been on ART for at least 24 months and on potent ART for at least 6 months. Must be able to continue cART during the study, agree to come to all study visits, be able to swallow a pill, and be willing to communicate regularly with the study team. Since we are studying the safety of this new approach, all participants must confirm inability to get pregnant (women) or demonstrate use of two reliable birth control methods during the study (men with female partners).

Not eligible if: Difficulties with having your blood drawn; active syphilis, hepatitis B, or hepatitis C infection; known heart conditions; active chemotherapy or radiation treatment; receiving any other study drug within 1 month of this study; known resistance to certain classes of HIV medications, low red blood cell count (anemia). There may be other reasons that you might not be able to participate - the study team can help figure out if you qualify.

Number of Visits

    » 26 In person visit(s)

    Clinic visits with 3 blood procedures

    » 0 Remote visit(s)

Participation Period

up to 15 months (1 year and 3 months)

Compensation

up to $3750 for completion of all study visits and procedures. Travel reimbursement may be available for participants travelling more than 50 miles.

By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.