A5359: A Phase III Study to Evaluate Long-Acting Antiretroviral Therapy in Non-adherent HIV-Infected Individuals

Q: HIV treatment using Long-Acting injectable ART will be a more successful therapy compared to a Standard of Care oral ART regimen in keeping previously non-adherent, HIV-infected individuals on treatment and virologically suppressed.
POP: ART-experienced, HIV-infected males and non-pregnant females ≥ 18 years of age with non-adherence to their HIV medications and an HIV-1 RNA >200 copies/mL.
MED: Oral and Long-Acting injectable Cabotegravir and Rilpivirine.
DUR: Up to 3.5 years.
CALL: Becky Straub, RN, 919-843-9975

IRB 17-3172: Blood Sampling Protocol for Resting CD4 Cells

Q: To obtain blood samples from virally suppressed, HIV positive patients, on anti-retroviral
regimens to test the efficacy of a novel cell culture vessel to determine optimal dosing combinations and frequencies.
POP: 50 HIV positive adults, >18yo, adherent, undetectable. On any FDA-approved ART, for
at least 2-4 years, exclusive of protease inhibitors.
DUR: Single blood draw visit.
CALL: Heather Prince, PA-C, 919-962-5344

IGHID 11801: The HIV Reservoir in Women: Implication for HIV Cure Strategies

Q: To characterize HIV reservoir size, stability, and persistence in women as well as evaluate approaches to disrupt HIV latency in women.
POP: HIV-1 infected women, ≥18 and ≤ 62 years of age, on stable cART with HIV-1 RNA levels < 50 copies/mL for at least 12 months, as measured on standard HIV RNA assays. Eligible participants must have a CD4 cell count ≥ 300 cells/mm3.
DUR Up to 4 years.
CALL: Francesca Prince, 919-966-8794 or 919-428-7612 or Caroline Baker, 919-966-2623

MGD014-01 – Dart Study: A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

Q: Characterize the safety and tolerability of MGD014 administered intravenously (IV) to HIV-infected participants maintained on suppressive ART.
POP: HIV-1-infected adults (18 to 65 years old) on ART with plasma HIV RNA < 50 copies/mLfor 24 months prior to enrollment.Eligible participants must be on stable combination ART (cART) and have a CD4 count ≥ 350 cells/mm3.
MED: MGD014 administered via a single infusion in Part 1 or a weekly infusion, for 6 weeks, in Part 2.
DUR: 10 weeks (Part 1) or 20 weeks (Part 2).
CALL: Susanne Henderson, RN, 919-843-4375 or Becky Straub, RN, 919-843-9975.

IGHID 11802 – VOR-07 Study: Combination Therapy with the Novel Clearance Modality (VRC07-523LS) and the Latency Reversal Agent (Vorinostat) to Reduce the Frequency of Latent, Resting CD4+ T Cell Infection

Q: To evaluate the safety and tolerability of combination therapy with VRC07-523LS and VOR in HIV-infected participants on cART.
POP: Healthy men and women of any race with HIV-1 infection, ages 18 through 64, suppressed on ART therapy for > 24 months. Eligible participants must have a CD4 cell count ≥ 300 cells/mm3.
MED: Vorinostat and VRC07-523LS.
DUR: 36 weeks.
CALL: JoAnn Kuruc, RN, 919-966-8533