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- 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 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
A5317- Effects of Telmisartan on Fibrotic and Inflammatory Contributors to End-Organ Disease in HIV-Infected Patients Well Controlled on Antiretroviral Therapy (TRAFIC Study)
- Question: To see if a drug called telmisartan will decrease fibrosis (scarring) and inflammation (irritation) in people who are infected with HIV and doing well on their HIV medications.
- Population: HIV-infected men and women ≥ 18 years of age who have been on stable ART for at least 24 weeks prior to Step 1 entry and who have both HIV-1 RNA < 200 copies/mL for at least 24 weeks prior to Step 1 entry (a single blip to ≤500 copies/mL in the 24 weeks prior to Step 1 entry will be allowed and < 50 copies/mL at screening
- Medicine: Telmisartan
- Duration: 48 weeks (about 1 year) including 9 clinic visits
- Call: Chris Evans (919) 843-8759; David Currin, RN (919) 966-2624 or Pager (919) 216-2406
A5321: Decay of HIV-1 Reservoirs in Subjects on Long-Term Antiretroviral Therapy: the ACTG HIV Reservoirs Cohort (AHRC) Study
- Question: The purpose of this study is to examine longitudinal changes in HIV-1 reservoirs among HIV-1 infected subjects receiving antiretroviral therapy (ART)
- POP: About 20 HIV-infected men and women, ≥ 18 years of age who meet the following group-specific criteria:
- Group 1: Virologically suppressed for ≥ 2 years with no HIV-1 RNA values > 50 copies/mL at or after 48 weeks of ART
- Group 2: Initiated ART within 45 days after AHI diagnosis, virologically suppressed for ≥ 2 years, and no HIV-1 RNA values > 50 copies/mL at or after weeks of ART.
- Group 3: HIV-1 RNA <500 copies/mL prior to ART initiation, virologically suppressed for ≥1 year, and no HIV-1 RNA values >50 copies/mL at or after 48 weeks of ART.
- MED: This is an observational study; no treatment is provided.
- DUR: Up to 7 years. All subjects will undergo twice yearly blood and hair sample collections for immunologic, virologic, and pharmacologic evaluations, and every-other-year assessments of the HIV-1 reservoirs
- CALL: David Currin 919-966-2624; Erin Hoffman 919-843-0720; 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: Emily Barrows (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 0123 - 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
IGHID 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-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 cell/mm3
- Medication: 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: Emily Barrows (919) 966-7747