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.
- POP: 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.
- MED: Low dose methotrexate (LDMTX)
- DUR: 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 your HIV medications.
POP: HIV+ patients >18 years who have been taking a combination of antiretroviral drugsthat 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.
- MED: Romidepsin (Istodax®)
- DUR: 4 weeks/28 days
- CALL: Donna Pittard (919) 843-6512
A5316 - Evaluating Pharmacokinetic Interactions with Vaginal Ring Contraceptives and Antiretroviral Therapy
- Question:To evaluate pharmacokinetic (PK) interactions between hormonal contraception (etonogestrel and ethinyl estradiol) delivered via a vaginal ring and efavirenz (EFV) or atazanavir/ritonavir (ATV/r)- based regimens in HIV-infected women.
- POP: HIV-infected, non-pregnant women ≥18 years old, interested in using the vaginal ring (NuvaRing), either on a targeted ART regimen as listed below or not on ART regimen as listed below or not on ART
- MED: Etonogestrel/ethinyl estradiol vaginal ring (NuvaRing), efavirenz (EFV), atazanavir/ritonavir (ATV/r)
- DUR: 28 days from study entry through the final clinic visit. If participants choose to use an optional vaginal ring after day 28, they will receive a followup phone call on day 56.
- CALL: Erin Hoffman (919) 843-0720; Miriam Chicurel-Bayard (919) 843-9922
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.
- POP: HIV-infected men and women ≥18 years of age who have been on stable ART for atleast 48 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.
- MED: Telmisartan
- DUR: 48 weeks (about 1 year) including 9 clinic visits
- CALL: Chris Evans 919-843-8759
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 Suppressive 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.
- POP: 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.
- MED: Isotretinoin
- CALL: David Ragan 919-966-2623
IGHID 1309 - A Phase I Study to Evaluate the Kinetics of the Immunologic Response and Virologic Imp[act of AGS-004 in HIV infected Individuals Suppressed on Antiretroviral Therapy Initated during Acute and Chronic HIV Infection.
- Question: To evaluate and compare 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.
- POP: HIV-infected men and women must be ≥18 and <65 years of age and on stable ART. HIV-infected participants whose viral production is suppressed by combination antiretroviral therapy (cART) as measured on standard HIV RNA assays for ≥ one year. Eligible participants must have a CD4 count ≥350 cells/mm3.
- MED: AGS-004 as a series of 4 vaccinations
- DUR: 48 weeks (12 weeks in screening, 32 weeks
- CALL: Corazon Halsey, ANP (919) 966-8524