Clinical trial NCT02527096 (phase 2, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: dolutegravir (tivicay®) - phase 1, lamivudine (epivir®) - phase 2, dolutegravir (tivicay®) - phase 2
SMILES: N[C@@H](CO)C(O)=O, CC1=CN([C@H]2C[C@H](N=[N+]=[N-])[C@@H](CO)O2)C(=O)NC1=O, N[C@@H](CO)C(O)=O
Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infected patient

          -  Age ≥ 18 years

          -  CD4 cell count nadir > 200/mm3

          -  Genotype on pre-HAART interpreted with the last version of the ANRS AC11 resistance
             group's algorithm which presents:

               -  no major mutation on protease among: D30N, V32I, M46I/L, I47A/V, G48V, I50L/V,
                  154M/L, L76V, V82A/F/T/S, I84V, N88D/S, L90M,- no mutation on RT (except the
                  mutation A98S if the patient is not infected by the virus subtype C),

               -  no mutation on integrase (if the genotype is available),

          -  First-line treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, 1 NNRTI or
             1 INI). The initial treatment may have changed a maximum of two times but only once
             for toxicity (changes such Epivir / Ziagen to Kivexa, are not considered as a change
             of treatment). However, treatment has to be unchanged in the last 6 months

          -  Plasma HIV RNA ≤ 50 copies/mL for ≥ 2 years with at least 2 viral load determinations
             per year. Blips (HIV viral load between 50 and 200 copies/mL but ≤ 50 copies/mL on
             control sample) are allowed except in the last 6 months. The total number of blips
             must not exceed 3 in the last 2 years

          -  Negative Hepatitis Bs Antigen

          -  Effective contraception for women of childbearing potential

          -  Informed consent form signed by patient and investigator

          -  Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid
             ("Aide Médicale d'Etat" AME in France) is not a Social Security programme)

        Exclusion Criteria:

          -  HIV-2 infection

          -  Positive HBc Ac isolated

          -  Hepatitis B Virus (HBV) co-infected patients (positive Hepatitis Bs Ag at inclusion)

          -  Chronic hepatitis C currently treated or needing therapy in the next 12 months

          -  History of HIV-associated neurocognitive disorders

          -  Current pregnancy or breastfeeding

          -  No effective contraception for the women of childbearing

          -  Previous treatment with chemotherapy (except bleomycin on Kaposi disease's treatment)
             or immunotherapy

          -  Grade > 2 abnormality for usual biological parameters (liver function tests, blood
             cell count)

          -  ALT(Alanine Aminotransferase) ≥ 5 x upper limit of normal value (ULN) or AST
             (Aspartate Aminotransferase) ≥ 3 x ULN and bilirubinemia ≥ 1.5 x ULN (with 35% direct
             bilirubinemia)

          -  Unstable liver disease (ascitis, encephalopathy, coagulopathy, hypoalbuminemia,
             oesophageal or gastric varices or persistent jaundice)

          -  Known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic
             gallstones)

          -  Creatininemia clearance below 50 mL/min (Cockroft-Gault method)

          -  History or presence of allergy to the trial drugs or their components

          -  Severe hepatic insufficiency (Child Pugh Class C)

          -  Patients participating in another clinical trial including an exclusion period that is
             still in force during the screening phase

          -  Patients under "sauvegarde de justice" (judicial protection due to temporarily and
             slightly diminished mental or physical faculties) or under legal guardianship.