A Phase IIb, 96 week, randomised, partially double-blinded, multicentre, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of GW873140 in combination with COMBIVIR (lamivudine and zidovudine) upon selected immunological and virological markers of HIV-1 infection in antiretroviral therapy naive adults

INTERVENTION: Product Name: NA Product Code: NA Pharmaceutical Form: Film‐coated tablet CAS Number: 461023‐63‐2 Current Sponsor code: GW873140 Other descriptive name: NA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200‐ Trade Name: COMBIVIR*60CPR BL 150/300MG Product Name: NA Product Code: NA Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Zidovudine CAS Number: 30516‐87‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ INN or Proposed INN: lamivudine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Trade Name: SUSTIVA*600MG 30 CPR Product Name: NA Product Code: NA Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Efavirenz CAS Number: 154598‐52‐4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ CONDITION: GW873140 in combination with COMBIVIR (lamivudine and zidovudine) upon selected immunological and virological markers of HIV‐1 infection in antiretroviral therapy naive adults. ; MedDRA version: 6.1 Level: PT Classification code 10020161 PRIMARY OUTCOME: Main Objective: Primary end point(s): Secondary Objective: INCLUSION CRITERIA: Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range