Treatment Experienced: Suppressed


A5315 A Phase I/II Study of Single Dose Romidepsin in HIV-Infected Adults with Suppressed Viremia on Antiretroviral Therapy to Assess Safety, Tolerability, and Activation of HIV-1 Expression

  • Question: To identify single doses of Romidepsin (RMD) that are safe and well-tolerated in HIV-infected persons on antiretroviral therapy (ART), and that can awaken the latent or sleeping HIV allowing it to be targeted by HIV medications
  • Population: HIV+ patients >18 years of age who have been taking a combination of antiretroviral drugs that does not include a protease inhibitor for at least the past 3 months; and whose HIV-1 RNA level (viral load, the amount of HIV in the blood) has been less than 50 copies/mL plasma, or below the limit of detection, for the past 24 months
  • Medication: Romidepsin (Istodax®)
  • Duration: 4 weeks/28 days
  • Call: Donna Pittard, RN 919-843-6512

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

  • Question: 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
  • Population: 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
  • Medication: 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
  • Duration: 96 weeks
  • Call: Susan Blevins, 919-843-8763 or Jonathan Oakes 919-966-6712

A5332 REPRIEVE - Randomized Trial to Prevent Vascular Events in HIV

  • Question: Primary objective is to determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events in HIV infected persons
  • Population: 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.
  • Medication: Pitavastatin 4mg PO daily OR placebo for Pitavastatin
  • Duration: Study schedule involves screen, entry, month 1 and then 4 visits per year for 6 years
  • Call: Jonathan Oakes (919) 966-6712, Erin Hoffman (919) 843-0720

A5337 - A Phase I/II, Open Label, Single Arm, Pilot Study to Evaluate the Safety of Sirolimus and its Efficacy with Respect to its Effects on HIV-1 Reservoir Size and Immune Function

  • Question: To assess the effects of sirolimus on HIV-1-specific CD8+ T-cell function, HIV transcription, and residual viral production
  • Population: HIV-infected men and women ≥ 18 years of age, maintained on suppressive antiretroviral therapy (ART) for ≥24 months with CD4+ cell count ≥400 cells/mm3. Subjects may not be on a PI-based or cobicistat-based regimen 3 months prior to and at any time after study entry and must remain on ART during sirolimus study treatment.
  • Medication: For subjects on a non-protease inhibitor (PI), non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen: Sirolimus 0.025 mg/kg/day initial dose for 20 weeks
    For subjects on a
  • Duration: 44 weeks (12-week pre-sirolimus treatment lead-in period, followed by 20 weeks of sirolimus treatment and an additional 12 weeks off sirolimus treatment)
  • Call: Chris Evans, ANP, 919-843-8759

A5346 - Randomized, Double-Blinded, Placebo-Controlled Trial of a Dipeptidyl Peptidase-4 Inhibitor (Sitagliptin, Januvia) for Reducing Inflammation and Immune Activation in HIV-Infected Men and Women

  • Question: To evaluate if Sitagliptin/Januvia reduces immune activation markers and circulating levels of inflammatory biomarkers in HIV-infected subjects
  • Population: HIV- infected men and women ≥18 years of age with CD4 count between 100 and 350, virologically suppressed <75 copies, on continuous ART for >48 weeks and current ART regimen for a minimum of 12 weeks. Acceptable ARV regimens include at least 2 NRTI's and either a protease inhibitor boosted with ritonavir an integrase inhibitor, or an NNRTI. Eligible subjects must have no history of pancreatitis, diabetes mellitus, or current dx of congestive heart failure and ingest no immunomodulators, anti diabetic meds, hormonal anabolic meds, or systemic steroid.
  • Medicine: Sitagliptin 100 mg tablet or placebo once daily
  • Duration: 20 weeks (16 weeks of drug treatment or placebo, followed by 4 week observation period)
  • Call: Donna Pittard, RN, 919-843-6512 or pager 919-216-1336

Status: On-going / Recruiting

A5350 - Safety, Tolerability and Effects of the Probiotic Visbiome Extra Strength on Gut Microbiome and Immune Activation Markers in HIV-Infected Participants on Suppressive Antiretroviral Therapy: A Phase II Study

  • Question: To evaluate whether there is a significant change in sCD14 after 24 weeks of probiotic therapy, and to determine the safety and tolerability of Visbiome Extra Strength in HIV-infected participants on stable ART
  • Population: HIV- infected adults (≥18) on stable ARV's for ≥ 24 weeks prior to entry, HIV-1 RNA ≤50 copies/mL for 48 weeks, with CD4 ≥ 200
  • Medicine: 1 sachet Visbiome Extra Strength daily for 2 weeks, 1 sachet Visbiome Extra Strength twice daily for 22 weeks or placebo
  • Duration: 38 weeks
  • Call: Jonathan Oakes, 919-966-6712

Status: On-going / Recruiting

GS-US-380-1878 - A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamiduvine to GS-9883/Emtricitabine/Tenofivir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

  • Question: To evaluate the safety and efficacy of switching from regimens consisting of boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamiduvine to GS-9883/Emtricitabine/Tenofovir Alafenamide
  • Population: HIV-1 infected subjects ≥ 18 years old who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable regimen containing boosted ATV or DRV plus either FTC/TDF or ABC/3TC administered orally, once daily with food. (Note: Participants must supply current ARV regimen if randomized to remain on current ARV regimen
  • Duration: At least 48 weeks
  • Call: David Currin, RN, 919-966-2624

GS-US-292-1825 - A Phase 3b Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of E/C/F/TAF Fixed Dose Combination (FDC) in HIV-1 Infected Subjects on Chronic Hemodialysis

  • Question: To evaluate the safety and tolerability of EVG/COBI/FTC/TAF fixed dose combination in HIV-1 infected adults with end stage renal disease on chronic hemodialysis
  • Population: HIV-infected adults (≥ 18) with ESRD on chronic HD for ≥ 6 months and HIV-1 RNA ≤50 copies/mL on stable ARV's for ≥ 6 months and HIV-1 RNA ≤50 copies/mL on stable ARV's for ≥ 6 months, with CD4 ≥ 200
  • Medication: EVG/COBI/FTC/TAF fixed dose combination
  • Duration: 48 weeks
  • Call: Donna Pittard, RN, 919-843-6512 or pager 919-216-1336
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CID 0819 - Apheresis Procedures to Obtain Leukocytes from HIV+ Subjects

  • Question: Investigate new methods of activating resting HIV infected cells in laboratory
  • Population: VL < 50; CD4 >300 and on HAART for >6months
  • Duration: up to 3 years
  • Call: Amanda Crooks 919-843-9564

IGHD 11409

  • Question: 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
  • Population: VL < 50; and suppressed on HAART for > 12 months
  • Duration: up to 8 months
    • Cohort A: Blood samples collected once a week for 8 consecutive weeks
    • Cohort B: Blood samples collected once a month for 8 consecutive months
  • Call: Amanda Crooks 919-843-9564

Status: On-going / Recruiting

IGHID 1320 - The HXTC Study - A Phase I Study to Evaluate the Safety, Immunologic and Virologic Responses of HIV-1 Antigen Expanded Specific T Cell Therapy (HXTC) as a Therapeutic Strategy in HIV-infected Individuals Started on Antiretroviral Therapy During Acute and Chronic Infection

  • Question: Evaluate the kinetics of the immunologic and virologic impact of HXTC in HIV-infected individuals on suppressive cART initiated during acute versus chronic HIV infection.
  • Population: HIV-infected men and women must be ≥18 and ≤ 65 years of age and on satble ART. Viral suppression and on combination antiretroviral  therapy (cART). Eligible participants must have a CD4 count ≥350 cells/mm3.
  • Medication: Expanded Specific T Cell Therapy
  • Duration:6 - 9 months
  • Call: JoAnn Kuruc, RN 919-966-8533

IGHID 11424 - The Effect of Vorinostat and AGS-004 on Persistent HIV-1 Infection (The VOR VAX Study)

  • Question: 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)
  • Population: 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
  • Medication: Vorinostat and AGS-004 as a series of 4 vaccinations
  • Duration: up to 2 years
  • Call: JoAnn Kuruc, RN 919-966-8533

IRB 15-2865 Antiretroviral Localization in the Gut-Associated Lymphoid Tissue and Lower Female Genital Tract Tissue of HIV+ Subjects

  • Question: To characterize and quantify the distribution of several antirerovirals within suspected tissue reservoirs of HIV
  • Population: 22 HIV-infected women ≥ 18 years of age who have been virally suppressed for > 3 months. Blood plasma, female genital tract (vaginal and cervical), and gut (ileal and rectal) biopsies to be collected for imaging
  • Medication: On a regimen containing TFV/FTC and one of the following: raltegravir, efavirenz, atazanavir, maraviroc
  • Duration: Up to 7 weeks (enrollment within 42 days of screening, one 36-hr. inpatient stay, follow-up within 2 weeks)
  • Call: Heather Prince, PA-C, 919-962-5344 or Corbin Thompson, PharmD, 919-843-0321




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.