A prospective, randomized, open-label trial of two abacavir/lamivudine based regimen (ABC/3TC + darunavir/ritonavir or ABC/3TC + raltegravir) in late presenter naïve patients (with CD4 count <200 cells/µL - advanced HIV disease)

INTERVENTION:

Trade Name: KIVEXA*FL 30CPR RIV 600MG+300M Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

ABACAVIR SULFATE CAS Number: 188062‐50‐2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ INN or Proposed

INN:

LAMIVUDINE CAS Number: 134678‐17‐4 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 300‐ Trade Name: ISENTRESS*FL 60CPR RIV 400MG Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

RALTEGRAVIR POTASSIUM CAS Number: 871038‐72‐1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: PREZISTA*60CPR RIV 400MG Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

DARUNAVIR ETHANOLATE CAS Number: 635728‐49‐3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400‐ Trade Name: NORVIR*FL 30CPR RIV 100MG Pharmaceutical Form: Film‐coated tablet INN or Proposed

INN:

RITONAVIR CAS Number: 155213‐67‐5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐

CONDITION:

Advanced HIV disease, defined as a CD4 cell count <200 cells/µL or the presence of an AIDS‐defining event. ; MedDRA version: 14.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 ‐ Infections and infestations Therapeutic area: Diseases [C] ‐ Virus Diseases [C02]

PRIMARY OUTCOME:

Main Objective: Proportion of patients with undetectable viremia (HIV‐1 RNA<50 copies/mL) after 48 weeks Primary end point(s): Proportion of patients with undetectable viremia (HIV‐1 RNA<50 copies/mL) after 48 weeks Secondary Objective: Change in CD4+ cell count from baseline through week 48; Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart. Timepoint(s) of evaluation of this end point: 48 weeks

SECONDARY OUTCOME:

Secondary end point(s): Time to virological rebound, defined as plasma HIV RNA >50 copies/mL measured on two consecutive occasions at least one month apart. Timepoint(s) of evaluation of this end point: 48 weeks

INCLUSION CRITERIA:

1. Males or females aged 18‐64 years who are HIV‐1 antibody seropositive, with a CD4 count <200 cells/uL. 2. All patients should be antiretroviral‐naive 3. All patients should be HLA B57 or HLA B5701 negative 4. Patients must have an HIV RNA level <500,000 copies/mL 5. Patients with an active opportunistic infection could be enrolled as long as this was diagnosed more than 2 weeks prior to screening. 6. Patients must meet the following laboratory criteria. Neutrophil count ? 1,000 cells/mm3 Haemoglobin > 9.0 grams/dl (men and women) Platelet count = 75,000 cells/mm3 Alkaline phosphatase < 3.0 the upper limit of normal ALT and AST < 3.9 times the upper limit of normal Total bilirubin < 1.5 times the upper limit of normal. 7. Female patients of childbearing potential must be willing to use a reliable form of contraception, which will include a medically approved form of barrier contraception. 8. Patients must be able to provide written consent to c