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GSK1349572 Open label Protocol EAP

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
GSK1349572NCT01536873

A GSK1349572 Open label Protocol for HIV infectected, Adult patients with Integrase Resistance

Status: Active

Purpose / Objectives

Diagnosis

HIV-1 infection with documented RAL or ELV resistance

Target population

Age

18-99

Inclusion criteria

  • Adult subjects greater than 18 years of age
  • documented HIV-1 RNA >/= 400 c/mL
  •  documented raltegravir or elvitegravir resistance
  • inability to construct a viable background ART regimen with commercially available medications

Exclusion criteria

  •  Creatnine clearance < 30ml/min via Cockcroft- Gaultmethod
  •  females who are pregnant and/or breastfeeding
  • patients with known integrase allergic reaction 
  •  ALT > 5 times the ULN within one month of treatment initiation
  •  ALT > 3 times ULN and total bilirubin >1.5 times ULN
  •  evidence of severe hepatic impairment
  • patients eligible for, and have access to, an actively enrolling DTG Phase III clinical study, any condition or any active clinically significant disease during screening, anticipated requirement for any prohibited concomitant medications

Study design

  • Multicenter
  • Open Label

Intervention

ConditionIntervention
Infection, Human Immunodeficiency Virus Drug: dolutegravir

Documents (password protected)

Responsibilities in overall study

ViiV Healthcare

  • Tel. +44 (0)20 8380 6200