Treatment Experienced: Suppressed

 

A5314 - Effect of Reducing Inflammation with Low Dose Methotrexate on Inflammatory Markers and Endothelial Function in Treated and Suppressed HIV Infection

  • Question: To evaluate the safety and efficacy of low dose methotrexate (LDMTX) for the treatment of HIV-associated inflammation
  • Population: HIV-infected men and women ≥40 years old who have been virologically suppressed on continuous antiretroviral therapy for at least 24 weeks, who have a CD4+ T-cell count ≥400 cells/mm3; AND who have documented cardiovascular disease (CVD) or who are at increased risk
  • Medication: Low dose methotrexate (LDMTX)
  • Duration: 36 weeks (24 weeks of drug treatment/placebo followed by observation for an additional 12 weeks)
  • Call: Chris Evans 919-843-8759

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

A5326 Safety, Pharmacokinetics and Immunotherapeutic Activity of an Anti-PD-L1 Antibody (BMS-936559) in HIV-1 Infected Participants on Suppressive cART: A Phase I, Double-Blind, Placebo-Controlled, Ascending Single Dose Study

  • Population:HIV infected men and women between the ages of 18-70 who are on ART and have had an undetectable VL for 2 years or more with a CD4 count ≥350
  • Medication: A single dose of BMS-936559, which is an anti-PD-L1 monoclonal antibody
  • Duration: 1 year
  • Call: Becky Straub, RN 919-843-9975

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, or Miriam Chicurel-Bayard (919) 843-9922

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 919-843-8759

A5342 - A pilot study to measure the impact of a human monoclonal antibody, VRC-HIVMAB060-00-AB (VRC01) on Markers of HIV persistence in blood in ART-treated, HIV infected adults

  • Question: To see if VRC01 is safe and well tolerated in individuals with HIV and also to see if it helps to remove HIV infected cells from the body. A new test will be used to measure the amount of HIV in the T-Cells.
  • Population: HIV- infected person between the age of 18-60, on stable ARV for at least 2 years and no changes in drug regimen for the past 90 days. CD4 > 200, undetectable HIV viral load for the past 2 years, no chronic Hep B or Hep C
  • Medicine: VRC01 will be administered in a saline IV infusion dosed at 40mg/kg of weight. It will be administered over 60 minutes or longer. Patients must continue to take their prescribed HIV medicantions.
  • Call: David Currin, RN at 919-966-2624

Status: On-going / Recruiting

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 Sitabliptin/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 100 - 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 immunomudulators, antidiabetic 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 at 919-843-6512 or pager 919-216-1336

Status: On-going / Recruiting

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

  • Question: Investigate new methods of activating resting HIV infected cells in laboratory
  • Population: HIV positive participants with a viral load <50, CD4 >350, and who have been on HAART >6 months.
  • Duration: Up to 3 years.
  • Call: Amanda Crooks 919-843-9564

Status: On-going / Recruiting

GSK 201637 SWORD-2 Phase III, Randomozed, Multicenter, Parallel-Group, Noninferiority Study Evaluating the Efficacy, Safety and Tolerability of Switching to Dolutegravir Plus Rilpivarine from Current INI-,NNRTI-or PI-Based Antirretroviral Regimen in HIV-1 Infected Adults Who Are Virologically Suppressed

  • Question: This study is being conducted to establish if human immunodeficiency virus type 1 (HIV-1) infected adult subjects with current virologic suppression on a regimen with 2 nucleosides reverse transcriptase inhibitors (NRTI's) + a third agent remain suppressed upon switching to a two-drug regimen with dolutegravir (DTG) + rilpivirine (RPV).
  • Population: HIV-1 infected adults whose HIV-1 viral load is suppressed on combination antiretroviral therapy (cART) containing 2 NRTI's plus a third agent (INI, NNRTI, or PI).
  • Medicine: There is an Early Switch Phase, and Late Switch Phase. In the Early Switch Phase: Subjects who fulfill all eligibility requirements will be randomly assigned 1:1 to receive DTG 50 mg + RPV 25 mg once daily, to be taken with a meal, or continue their current ARV regimen to Week 52. At Week 53, Late Switch Phase, subjects randomly assigned to continue their current ARV regimen during the Early Switch Phase and with HIV-1 RNA <50 c/ml, will switch to DTG 50 mg + RPV 25 mg once daily and be followed until Week 148. Subjects randomly assigned to DTG + RPV during the Early Switch Phase will continue on that treatment arm through Week 148.
  • Duration: 148 weeks
  • Call: Donna Pittard 919-843-6512

Status: On-going / Recruiting

IGHD 11409

  • Question: Evaluate the kinetics of the immunologic and virologic impact of AGS-004 in HIV-infected individuals on suppressive cART initiated during acute versus chronic HIV infection.
  • Population: VL < 50; CD4 >300 and on HAART for >6months
  • Duration: up to 3 years
  • Call: Amanda Crooks 919-843-9564

Status: On-going / Recruiting

IGHD 1309 - A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Impact of AGS-004 in HIV infected Individuals Suppressed on Antiretroviral Therapy Initiated during Acute and Chronic HIV Infection

  • Question: Evaluate the kinetics of the immunologic and virologic impact of AGS-004 in HIV-infected individuals on suppressive cART initiated during acute versus chronic HIV infection.
  • Population: HIV-1 infected men and women must be ≥ 18 and < 65 years of age and on stable ART. Viral supression and on combination antiretroviral therapy (cART). Eligible participants must have a CD4 count ≥ 350 cells/mm3
  • Medicine: AGS-004 as a series of 4 vaccinations
  • Duration: 44 weeks total (12 weeks in screening, followed by 32 weeks inclusive of dosing and immune monitoring)
  • Call: JoAnn Kuruc, RN 919-966-8533

Status: On-going / Recruiting

IGHD 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 stable 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 919-966-8533

Status: On-going / Recruiting

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

TMC114IFD3013 (EMERALD) - A Phase 3, randomized active-controlled, open-label study to evaluate the efficacy, safety and tolerability of switching to a darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once-daily single-tablet regimen versus continuing the current regimen consisting of a boosted protease inhibitor (bPI) combined with emtricitabine/tenofovir disoproxil fumerate (FTC/TDF) in virologically-suppressed, human immunodeficiency virus type 1 (HIV-1) infected subjects.

  • Question: To demonstrate noninferiority in efficacy of a D/C/F/TAF once-daily single-tablet regimen relative to continuing the current bPI combined with FTC/TDF in virologically-suppressed subjects, in regard to the proportion of virologic rebounders.
  • Population: HIV-1 positive individuals currently treated with a stable antiretroviral (ARV) regimen consisting of a bPI (limited to darunavir [DRV]) once daily with low-dose ritonavir [rtv] or cobicistat [COBI], atazanavir [ATV] with rtv or COBI, or lopinavir [LPV] with rtv) combined with FTC/TDF only, for at least 6 consecutive months preceding the screening visit, and with a suppressed viral load prior to and at screening.
  • Medication: Randomized 2:1 to the following treatment arms:
    • D/C/F/TAF Arm: Switch to regimen of an FDC tablet containing DRV 800 mg/ COBI 150 mg/ FTC 200 mg/ TAF 10 mg (further referred to as D/C/F/TAF tablet) once daily- Control Arm: Continue current regimen consisting of a bPI (limited to DRV once daily with rtv or COBI, ATV with rtv or COBI, or LPV/rtv) combined with FTC/TDF only
  • Duration: 48 weeks --then all subjects will enter the extension phase and receive D/C/F/TAF to week 96+
  • Call: Miriam Chicurel-Bayard, RN 919-843-9922

 


 

 

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.