A5324: A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing Antiretroviral Intensification with Maraviroc and Dolutegravir with No Intesification or Intesification with Dolutegravir Alone for the Treatment of Cognitive Impairment in HIV

Q: A Phase IV randomized, double-blinded, placebo-controlled study to assess the efficacy of adding Maraviroc (MVC) and Dolutegravir (DTG) to the current antiretroviral therapy of HIV-infected individuals who have mild to moderate neurocognitive impairment, with a primary outcome of improvement in neurocognitive performance
POP: Subjects will have HIV-associated neurocognitive disorder (HAND) as defined by the Frascati criteria, plasma HIV-1 RNA <50 copies/mL within 90 days prior to entry, and not more than one plasma HIV-1 RNA ≥50 and <200 copies/mL in the past 6 months prior to entry with a subsequent plasma HIV-1 RNA <50 copes/mL, and on stable ART for at least 12 months prior to entry with no plans to change treatment
MED: At entry, subjects will be randomized to one of the following:

  • Arm A: Add to their existing ART: placebo for MVC and placebo for DTG
  • Arm B: Add to their existing ART: DTG and placebo for MVC
  • Arm C: Add to their existing ART: MVC and DTG
DUR: 96 weeks
CALL: Jonathan Oakes 919-966-6712 or Susan Blevins, ANP-C, 919-843-8763

A5332: REPRIEVE – Randomized Trial to Prevent Vascular Events in HIV

Q: Primary objective is to determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events in HIV infected persons
POP: HIV infected adults 40-75 years of age, on ART >6months with CD4 > 100 that do not meet current guidelines for treatment with a statin.
MED: Pitavastatin 4mg PO daily OR placebo for Pitavastatin
DUR: Study schedule involves screen, entry, month 1 and then 3 visits per year for 4+ years
CALL: Jonathan Oakes (919) 966-6712 or Erin Hoffman (919) 843-0720

A5345: Identification of Biomarkers to Predict Time to Plasma HIV RNA Rebound and Post-Treatment Viral Control during an Intensively Monitored Antiretroviral Pause (IMAP)

Q: Analytic Treatment Interruption (ATI) Study to identify and validate biomarkers that predict time to initial viral rebound.
POP: Chronically HCV-infected, treatment naïve, with or without HIV-1 co-infection, with HCV genotypes 1-6.Participants with compensated cirrhosis will be eligible to participate in this study; however, the proportion of cirrhotics in the study will be restricted to no more than 20%. The number of HIV-1 co-infected participants will be restricted to no more than 50% of the study sample.
MED: 12 weeks of the fixed-dose combination of SOF/VEL.
DUR: 72 weeks: 12 weeks on treatment and 12 weeks post-treatment, and weeks 48 and 72 for SVR follow-up.
CALL: Jonathan Oakes, 919-966-6712 or David Currin, RN, 919-966-2624

A5360: Minimal Versus Standard Monitoring for the Delivery of All Oral Ribavirin-Free Pan Genotypic Directly Acting Antivirals to Chronically Infected Treatment Naïve HCV Populations Globally: MINMON Study

Q: Phase II open-label, study to assess the feasibility and efficacy of a minimal monitoring approach in chronically HCV-infected, treatment naïve participants, with and without HIV-1 co-infection, without decompensated cirrhosis.
POP: 66 men and women.Cohort B = 30 participants who initiated ART during acute infection

Cohort B = 30 participants who initiated ART during acute infectioN

MED: No medication is provided. Participants who enter study on an NNRTI will undergo switch to either a PI- or INSTI-based regimen.
DUR: Participants will be followed for up to 255 weeks from study entry.
CALL: Jonathan Oakes, 919-966-6712 or Donna Pittard, RN, 919-843-6512

CID 0819: Apheresis Procedures to Obtain Leukocytes from HIV+ Subjects

Q: Investigate new methods of activating resting HIV infected cells in laboratory
POP: VL < 50; CD4 >300 and on HAART for >6months
DUR: up to 3 years
CALL: Caroline Baker, 919-966-2623

CID 0819: Single Sample and Short Term Longitudinal Sample Collection

Q: Obtain blood sample to evaluate normal immune responses in virally suppressed HIV-1 positive person.
POP: VL < 50 and on ART for ≥ 24 months.
DUR: Up to 2 visits
CALL: Francesca Prince, 919-966-8794 or 919-428-7612 or Caroline Baker, 919-966-2623

CID 0819: Serial Blood Sample Collection

Q: Obtain serial blood samples from HIV infected participants to determine baseline variability in immune responses and inform what constitutes a significant change in T-cell responses following an intervention.
POP: VL < 50 and on ART for ≥ 24 months.
DUR: Up to 3 months with visits scheduled once a week for four weeks and then once a month for two consecutive months.
CALL: Francesca Prince, 919-966-8794 or 919-428-7612 or Caroline Baker, 919-966-2623

IGHD 11424 – The VOR VAX Study: The Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection

Q: Measure the potential of AGS-004 combined with Vorinostat to 1) stimulate expression of persistent proviral HIV from resting CD4+ cells, 2) generate an HIV-specific immune response, and 3) when combined, clear persistent infection in HIV-infected participants in whom viral replication and spread is inhibited by uninterrupted antiretroviral therapy (ART)
POP: Adult persons with HIV infection, on stable combination ART (c-ART) with viral suppression as measured on standard HIV RNA assays for ≥ 2 years. Eligible participants must have a CD4 count ≥ 300 cells/mm3
MED: Vorinostat and AGS-004 as a series of 4 vaccinations
DUR: Up to 2 years
CALL:  Susan Pedersen, RN, 919-966-6713 or JoAnn Kuruc, RN, 919-966-8533

IGHID 11627 – XTRA Study: A Phase I Study to Evaluate the Effects of Vorinostat and HIV-1 Antigen Expanded Specific T-Cell Therapy (HXTC) on Persistent HIV-1 Infection HIV-Infected Individuals Started on Antiretroviral Therapy

Q: The combination of HXTC therapy and multiple doses of VOR will result in a depletion of persistent, latent, replication-competent HIV infection
POP: HIV-infected men and women, ≥ 18 and < 65 years of age, with durable viral suppression as measured on standard HIV RNA assays for ≥ 24 months. Eligible participants must be on stable combination ART (cART) and have a CD4 count ≥ 350 cells/mm3
MED: Vorinostat and Expanded Specific T-Cell Therapy
DUR: Up to 48 months
CALL: Maureen Furlong, RN, 919-966-8794 or Becky Straub, RN, 919-843-9975
20, HIV-1 infected patients > 18 years of age with undetectable viral load and CD4 count > 300; no known cardiac hx or known resistance to ≥ 2 classes of drugs.