Treatment Naïve

A5353 - A study to Evaluate Dolutegravir plus Lamiduvine Dual Therapy for the Treatment of Naïve HIV-1 infected Participants

  • Question: In treatment-naïve participants, dual therapy with DTG plus 3TC is efficacious and well tolerated
  • Population: 120 HIV treatment naïve men and women 18 years of age or older
  • Medication: Dolutegravir 500mg daily and lamiduvine 300mg daily
  • Duration: 52 weeks
  • Contact: Becky Straub, RN 919-843-9975, bstraub@med.unc.edu

GS-US-380-1489 - A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamiduvine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

  • Question: To demonstrate the non-inferiority of the FDC of GS-9883/FTC/TAF versus ABC/DTG/3TC in ART treatment naïve adults
  • Population: HIV treatment naïve men and women 18 years of age or older, HIV RNA ≥ 500
  • Medication: GS-9883/FTC/TAF once daily or ABC/DTG/3TC once daily. GS-9883 is an integrase inhibitor
  • Duration: at least 96 weeks
  • Contact: Chris Evans, ANP, 919-843-8759

GS-US-380-1490 - A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Dolutegravir + Emtricitabine/Tenofovir Alafenamide in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults

  • Question: To demonstrate the non-inferiority of FDC GS-9883/FTC/TAF versus DTG + FTC/TAF in ART treatment-naïve adults
  • Population: HIV treatment-naive men and women 18 years of age or older, HIV RNA ≥ 500
  • Medication: GS-9883/FTC/TAF once daily or DTG co-administered with FTC/TAF once daily. GS-9883 is an integrase inhibitor
  • Duration: at least 96 weeks
  • Call: Chris Evans, ANP, 919-843-8759

TMC114FD2l-lTX3001 (AMBER)- A Phase 3, randomized, active-controlled, double-blind study to evaluate efficacy andsafety of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) once daily fixed dose combination regimen versus a regimen consisting of darunavir/cobicistat fixed dose combination co-administered with emtricitabine/tenofovir disoproxil fumarate fixed dose combination in antiretroviral treatment-naïve HIV type 1 infected subjects

  • Question: The primary objective is to demonstrate noninferiority in efficacy of a D/C/F/TAF fixed dose combination (FDC) tablet versus darunavir/cobicistat (DRV/COBI) FDC co-administered with emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) FDC in HIV type 1 (HIV-1) infected, antiretroviral (ARV) treatment-naïve adult subjects
  • Population: Men and women ≥ 18 years of age, who are infected with HIV and are ART naïve
  • Medication: darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) vs. darunavir/cobicistat fixed dose combination co-administered with emtricitabine/tenofovir disoproxil fumarate fixed dose
  • Contact: Becky Straub, RN 919-843-9975, bstraub@med.unc.edu

Status: On-going / Recruiting