Treatment Experienced: Failing

BMS AI438047A Multi-arm, Phase 3, Randomized, Placebo Controlled, Double-Blind Clinical Trial to Investigate the Efficacy and Safety of BMS-663068 in Heavily Treatment Experienced Subjects Infected with Multi-Drug Resistant HIV-1

  • Question: To assess the efficacy of BMS-663068 relative to placebo, when given on the background of a failing regimen, by determining the mean change in log 10 HIV-1 RNA from Day 1 (Baseline) to Day 8 in the Randomized Cohort.
  • Population: Male and female HIV-1 infected subjects ≥ 18 years of age with documented resistance, intolerability, and/or contraindications to ARV's in at least three classes, and who are failing their current ARV regimen with confirmed plasma HIV-1 RNA ≥ 400 copies/mL.
  • Medication: Randomized Cohort: On Day 1 throgh Day 8, approximately 150 subjects are dosed with blinded MBS-663068 600 mg twice a day, approximately 12 hours apart + current failing antiretroviral (ARV) therapy, and approximately 50 subjects are dosed with placebo twice a day, aproximately 12 hours apart + current failing ARV therapy. After day 8 subjects are dosed with open-label BMS-663068 600 mg twice a day, approximately 12 hours apart in combination with an Optimized Background Treatment (OBT). Non-Randomized Cohort: On Day 1, subjects will begin dosing with open-label BMS-663068 600 mg twice a day, aproximately 12 hours apart + OBT.
  • Duration: 48 weeks
  • Call: Donna Pittard 919-843-6512

GS-US-292-0117 A Phase 3, Two-Part Study to Evaluate the Efficacy of Tenofovir Alafenamide versus Placebo Added to a Failing Regimen Followed by Treatment with Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide in HIV-1 Positive, Antiretroviral Treatment-Experienced Adults

  • Question: To evaluate the efficacy of tenofovir alafenamide (TAF) versusplacebo, each administered with the existing, failing antiretroviral regimen, as demonstrated by the proportion of subjects with HIV-1 RNA decreases from baseline exceeding 0.5 log10 after 10 days of therapy in HIV-1 positive, antiretroviral treatment experienced adult subjects. To evaluate the efficacy and safety of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide single tablet regimen (E/C/F/TAF STR) after 24 and 48 weeks.
  • POP: ARV-experienced, with plasma HIV-1 RNA levels ≥ 500 copies/mLbut ≤100,000 copies/mL with documented primary resistance mutations to NRTIs as well as M184V and having at least one primary resistance mutation to NNRTIs and/or protease inhibitors (PIs).
  • MED: Part 1: Tenofovir alafenamide Part 2: Elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg
  • CALL: Becky Straub 919-843-9975

Status: On-going / Recruiting

GS-US-380-1878: A Phase 3, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Boosted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamiduvine to GS-9883/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed HIV-1 Infected Adults

  • Question: To evaluate the safety and efficacy of switching from regimens consisting of bossted Atazanavir or Darunavir plus either Emtricitabine/Tenofovir or Abacavir/Lamiduvine to GS-9883/Emtricitabine/Tenofovir Alafenamide
  • Population: HIV-1 infected subjects ≥ 18 years old who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable regimen containing boosted ATV or DRV plus either FTC/TDF or ABC/3TC for more than 6 months prior to screening and who are INSTI naïve.
  • Medication: FDC of GS-9883 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (GS-9883/F/TAF) administered orally, once daily without regard to food. Versus current antiretroviral drug regimen consisting of ritonavir or cobicistat boosted ATV or DRV plus either FTC/TDF or ABC/3TC administered orally, once daily with food. (Note: Participant must supply current ARV regimen if randomized to remain on current ARV regimen.
  • Duration: At least 48 weeks
  • Call: David Currin, RN 919-966-2624