Treatment Experienced: Suppressed

 

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

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: Blair Turner, NP 919-966-7747 or JoAnn Kuruc 919-966-8533

Status: On-going / Recruiting

A5279- A Phase III Clinical Trial of Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-Infected Patients with Latent Tuberculosis Infection

  • Question: To compare the efficacy of a 4-week daily regimen of rifapentine (RPT) plus isoniazid (INH) to a standard 9-month daily INH regimen for TB prevention in HIV-infected patients
  • Population: HIV positive participants > 18 years old with positive tuberculin skin test or positive serum IGRA
  • Medication: patients randomized to receive either daily weight-based rifapentine / INH x 4 weeks or daily INH x 36 weeks
  • Duration: 3 years after the last subject is enrolled
  • Call: Susan Pedersen 919-966-6713

Status: On-going / No longer recruiting

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 CVD risk.
  • Medicine: 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; David Currin, RN (919) 966-2624 or pager (919) 216-2406

Status: On-going / Recruiting

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: Identify single dose 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 your HIV medications.
  • Population: HIV+ patients > 18 years 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 your blood) has been less than 50 copies/mL plasma, or below the limit of detection for the past 24 months.
  • Medicine: Romidepsin (Istodax®)
  • Duration: 4 weeks/28 days
  • Call: Donna Pittard (919) 843-6512

Status: On-going / Recruiting

A5325- A Prospective Randomized Controlled Study to Evaluate the Effect of Isotretinoin on Immune Activation among HIV-1 Infected Subjects with Incomplete CD4+ T cell Recovery on Supprssive ART

  • Question: To evaluate the safety and tolerability of taking isotretinoin (a drug that is approved for use in the treatment of severe acne) at a high dose in HIV- infected subjects on antiretroviral therapy and whether it can help improve the immune system by repairing some of the damage that HIV does to a person's immune system.
  • Population: HIV-1 infected adults who have been virologically suppressed on ART for at least 12 months and with CD4+ T cell count <350 cells/mm3 at screening.
  • Medicine: Isotretinoin
  • Duration: 48 weeks (about 1 year) including 9 clinic visits
  • Call: Becky Straub 919-843-9975 or email

Status: On-going / Recruiting

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.        
  • Medicine: A single dose of BMS-936559, which is an anti-PD-L1 monoclonal antibody
  • Duration: 1 year
  • Call: Becky Straub 919-843-9975 or email

Status: On-going / Recruiting

 

CID 0807 - A Phase I/II Investigation of the Effect of Vorinostat (VOR) on HIV RNA expression in the Resting CD4+ T CElls of HIV-Infected Patients Receiving Stable Antiretroviral Therapy

  • Question: To compare HIV RNA expression and infection within resting CD4+ cells in HIV-infected patients on stable antiretroviral therapy (ART) before and after a single exposure to VOR and after exposure to interval dosing with VOR over several weeks.
  • Population: 30 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.
  • Medicine: VORINOSTAT
  • Duration: Can be up to 36 weeks, minimum of 20 weeks' time commitment
  • Call: Miriam Chicurel-Bayard 919-843-9922 or JoAnn Kuruc 919-966-8533

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: Blair Turner 919-966-7747

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

CID 1213 - Assessing Short and Long Term Compliance with Caloric Intake in HIV Positive Women after Switching to Fixed Dose Combination of Rilpivirine, Emtricitabine and Tenofovir DF

  • Question: This study will evaluate ease of compliance with the dietary requirement of this regimen in the population and determine association between caloric intake and virologic suppression
  • Population: HIV+ females ≥ 18 years of age, currently on ART with suppressed VL (<50 cps/mL 6 months prior to study entry), and no known resistance to FTC, TDF or ripivirine. Subjects must be willing to switch their ART to the study regimen (provided)
  • Duration: 48 weeks. Laboratory and clinical monitoring will remain with their HIV clinic provider
  • Call: Erin Hoffman (919) 843-0720

Status: On-going / No longer recruiting

 

 

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.