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VOR-07 Study

University of North Carolina at Chapel Hill


Description

This study is looking at combining 2 medications to evaluate the ability of the combination to decrease the size of the latent reservoir. We will test the use of an antibody called VRC07-523LS to stimulate the immune system to fight HIV infection. We will give the drug Vorinostat (VOR) to stimulate the release of HIV from the latent reservoir. Previous research studies show that VOR has the ability to stimulate some non-active HIV infected cells to become active and release HIV virus. The purpose of this study is to: • Evaluate the safety of VOR in combination with VRC07-523LS • Evaluate the safety of two series of a VRC07-523LS infusion followed by multiple oral doses of VOR • Determine if combining VRC07-523LS and VOR can have an impact on the size of the latent reservoir.


Keywords:

HIV/AIDS


Category:

Drug or Biologic
Phase:1

Qualifications

 


Age
18 - 64 years


Gender
Any


Study Population

Healthy men and women of any race with HIV-1 infection, ages 18 through 64, suppressed on ART therapy for > 24 months.


Investigator

Cindy Gay
Clinical Associate Professor
Medicine-Infectious Diseases

For questions, contact:

Donna Pittard and Francesca Prince
search4thecure@med.unc.edu
(919) 445-2772
Visit Website

Recruitment Period End

March 2, 2020

Location

Primary Location
Clinical & Translational Research Center
Burnett-Womack Building, 160 Dental Cir, Chapel Hill, NC 27514, USA
Secondary Location
UNC Hospital Apheresis Lab or American Red Cross Blood Donation Center in Durham, NC
101 Manning Dr, Chapel Hill, NC 27514, USA

Study Qualifications

Gender Any

Age Range 18 - 64 years

Participant qualification(s) • > or equal to 18 and < 65 years old • Able and willing to provide written informed consent • Willingness to provide written informed consent • Documentation of HIV-1 infection • On antiretroviral therapy (ART) for at least 2 years • Receiving a stable continuous combined ART regimen for at least 6 months or more • Able and willing to continue combined ART throughout the study • Able and willing to adhere to protocol therapy and study schedule and adhere to ART • HIV-1 RNA level <50 copies/mL • CD4 cell count ≥ 350 cells/mm3 • Does not have Hepatitis B or Hepatitis C or tuberculosis (TB) • Denies history of STIs including gonorrhea, chlamydia, syphilis, HIV, Hepatitis B, and Hepatitis C • All men and women must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) while on study and for 4 months after their last infusion. • All men participating in sexual activity that could lead to pregnancy must agree to consistently use at least one of the following forms of birth control for at least 21 days prior to Visit 3 and for 4 months after their last infusion: o Condoms (male or female) with or without a spermicidal agent o Diaphragm or cervical cap with spermicide o Intrauterine device (IUD) o Tubal ligation o Hormone-based contraceptive o Successful vasectomy • Able and willing to communicate effectively with study personnel • Able to access your veins for infusion and leukapheresis. • Able to swallow pills without difficulty. • Agree not to enroll on another study of an investigational research agent during the study period • Able and willing to be located easily by providing street address and telephone number (land line and/or cell phone number)

Not eligible if: • Have had problems getting your blood drawn, meaning that people have had a hard time • accessing your veins for blood donation in the past • Pregnant or breastfeeding • A woman of child bearing potential • Have a low red blood cell count, a condition called anemia • Have a known resistance to several classes of HIV medications • Cannot commit to taking your HIV treatment as indicated throughout the entire study • Cannot commit to completing all steps of the study • Are taking an investigational drug • Have taken more than 3 doses of Vorinostat in the past • Have untreated syphilis infection • Have previously received an HIV vaccine • Are receiving chemotherapy or radiation therapy for any active cancer • Weigh more than 253 pounds • Are taking medication for tuberculosis • Have diabetes • Have unstable asthma • Have a seizure disorder • Have a history of fainting or passing out within past 12 months

Number of Visits

    » 15 In person visit(s)

    1 Screening, 15 Clinic (including screening), 3 leukapheresis procedures

    » 8 Remote visit(s)

    8 phone contacts

Participation Period

36 weeks (9 months)

Compensation

Participants will receive the following compensation for participation in this study: • Study visits for routine blood draws and safety checks will be compensated $50 or the travel • reimbursement, whichever is greater (if participants travel 75 miles (or greater) one way to study visits, we will reimburse their additional travel) • Study visits that involve a leukapheresis will be compensated $200 (in addition to the travel distance compensation that exceeds $50) • Study visits that involve VRC07-523LS infusions will be compensated $200 (in addition to the travel distance compensation that exceeds $50) • Each VOR dose is compensated $50 (at home dosing and time compensated for contact with study coordinator) • The completion of each Symptom Assessment Log will be compensated $25 • Extra visits at UNC for repeat labs/evaluation will be compensated the same as routine study visits ($50 or the travel distance compensation, whichever is greater) • Extra visits for repeat labs at a local LabCorp will be compensated $15 If participants complete all of the study visits, they could receive a total of up to $2525.

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.