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HPTN 083: A Phase 2b/3 Double Blind Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women who have Sex with Men

Q:            To evaluate the safety and efficacy of the injectable agent, cabotegravir (CAB LA), for pre exposure prophylaxis (PrEP) in HIV-uninfected cisgender men and transgender women who have sex with men (MSM and TGW).

POP:        HIV-uninfected men who have sex with men (MSM) and transgender women (TGW) at risk for acquiring HIV infection, ages 18 or older.

MED:        Cabotegravir 600mg long acting injectable vs. Truvada 300/200mg daily oral medication.

DUR:        up to 4 years.

CALL:      Becky Straub, RN 919-843-9975 or Miriam Chicurel-Bayard, RN 919-843-9922

 Gemini:    A study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected treatment-naïve adults

Q:            To demonstrate the non-inferiority of DTG plus 3TC once daily compared to DTG plus tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) fixed-dose combination (FDC) once daily at 48 weeks.

POP:        700 HIV-1 infected treatment naïve men and women 18 years of age or older. HIV VL> 1000

Med:        Dolutegravir 50mg daily open label + either blinded 3tc 300mg daily OR blinded TDF/FTC 300/200mg daily.

DUR:        148 weeks planned with a continuation phase for Dolutegravir/3tc arm providing drug until FDC available or development terminated.

CALL:      Erin Hoffman 919-843-0720 or Susan Pedersen, RN 919-966-6713

 A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects with HIV and with Hyperlipidemia and/or Mixed Dyslipidemia

Q:            To evaluate the effect of 24 weeks of subcutaneous evolocumab administered monthly compared with monthly placebo on the percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in HIV+ subjects with hyperlipidemia or mixed dyslipidemia.

POP:        HIV+ adults, ≥18 years of age, on maximally tolerated statin therapy, on stable ARVs for ≥ 6 months, fasting LDL-C of ≥ 70 mg/dL or non-HDL-C ≥ 100 mg/dL and fasting triglycerides ≤ 600 mg/dL

MED:        Evolocumab, an FDA-approved drug, is a fully human monoclonal immunoglobulin G2 that specifically binds to and inhibits PCSK9, leading to decreased circulating concentrations of LDL-C. Administration is via subcutaneous injection.

DUR:        52 weeks

CALL:      Susan Blevins, ANP-C  (919) 843-8763