A clinical investigation study comparing elvitegravir with raltegravir, each administred with a background treatment in HIV-1 infected patients already on treatment with antiretroviral medicinal products

INTERVENTION: Product Name: Elvitegravir Product Code: EVG, GS‐9137 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Elvitegravir CAS Number: 697761‐98‐1 Current Sponsor code: GS‐9137/JTK‐303 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 85‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Isentress TM Tablets (Raltegravir tablets) Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Raltegravir CAS Number: 518048‐05‐0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: Elvitegravir Product Code: EVG, GS‐9137 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: Elvitegravir CAS Number: 697761‐98‐1 Current Sponsor code: GS‐9137/JTK‐303 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use CONDITION: Human Innunodeficiency Virus (HIV‐1) Infections ; MedDRA version: 15.0 Level: LLT Classification code 10020192 Term: HIV‐1 System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: To assess non‐inferiority of a regimen containing ritonavir��boosted elvitegravir versus raltegravir, each administered with a background regimen in HIV‐1 infected, antiretroviral treatment‐experienced adult subjects as determined by the proportion of subjects achieving and maintaining confirmed HIV‐1 RNA < 50 copies/mL through Week 48 Primary end point(s): The primary efficacy endpoint is the proportion of subjects achieving and maintaining; confirmed HIV‐1 RNA < 50 copies/mL through Week 48. Secondary Objective: To evaluate the efficacy, safety and tolerability of the two treatment regimens through 96 weeks of treatment; ; To evaluate the long‐term safety, tolerability, and efficacy of elvitegravir administered with a background regimen Timepoint(s) of evaluation of this end point: Week 48 SECONDARY OUTCOME: Secondary end point(s): ‐ Virologic response at Weeks 48 and 96 (HIV‐1 RNA < 50 copies/mL, snapshot analysis) ; ‐ The proportion of subjects achieving and maintaining confirmed HIV‐1 RNA < 50 copies/mL through Week 96 ; ‐ The proportion of subjects achieving and maintaining confirmed HIV‐1 RNA < 400 copies/mL through Weeks 48 and 96 ; ‐ The time to pure virologic failure for HIV‐1 RNA cutoff at 50 copies/mL up to Weeks 48 and 96 ; ‐ The time to pure virologic failure for HIV‐1 RNA cutoff at 400 copies/mL up to Weeks 48 and 96 ; ‐ The proportion of subjects with HIV‐1 RNA < 50 copies/mL at Weeks 48 and 96 ; ‐ The proportion of subjects with HIV‐1 RNA < 400 copies/mL at Weeks 48 and 96 ; ‐ The change from baseline in log10 HIV‐1 RNA (copies/mL) at Weeks 48 and 96 ; ‐ The change from baseline in CD4+ cell count at Weeks 48 and 96 Timepoint(s) of evaluation of this end point: Week 48 and week 96 INCLUSION CRITERIA: Exemptions for inclusion and exclusion criteria will not be granted. Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: • Plasma HIV‐1 RNA levels = 1,000 copies/mL at screening. • Stable antiretroviral regimen for at least 30 days prior to s • Subjects must have documented resistance, as defined by current IAS‐USA definitions (refer to Appendix 5 of the protocol), or at least six months experience prior to screening with two or more different classes of antiretroviral agents. Thus, subjects may have resistance to one class and at least six months experience prior to screening with a second class of antiretroviral agents, or resistance to two classes of antiretroviral agents, or at least six months experience with the two classes of antiretroviral agents. Subjects may also have resistance or at least six months experience prior to screening with three or more classes of antiretroviral agents.