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
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
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 firstname.lastname@example.org
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 email@example.com
A5331 - A Phase II Prospective, Double-Blind, Randomized, Placebo-Controlled 3-arm Clinical Trial of Aspirin 300 mg vs. 100 mg vs. Placebo for 12 weeks, Followed by a 4-week Washout Period, to Study Whether Aspirin Decreases sCD14 (soluble CD14) Levels in Peripheral Blood
- Question: To study whether aspirin decreases sCD14 levels in peripheral blood
- Population: Men and Women age 18 and over with HIV infection who have been on their HIV medications without interruption for 48 weeks or more and have had undetectable levels of HIV in their blood for at least 48 weeks
- Medicine: Arm 1: Aspirin 300 mg and placebo for aspirin 100 mg daily for 12 weeks, then follow up during washout for 4 weeks. Arm 2: Aspirin 100 mg and placebo for aspirin 300 mg daily for 12 weeks, then follow up during washout for 4 weeks. Arm 3: Placebo for aspirin 300 mg and placebo for aspirin 300 mg and placebo for aspirin 100 mg daily for 12 weeks, then follow up during washout for 4 weeks
- Duration: 16 weeks
- Call: Jonathan Oakes 919-966-6712
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
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
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.
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