a trial evaluating maintenance therapy with lamivudine (epivir®) and dolutegravir (tivicay®) in human immunodeficiency virus 1 (hiv-1) infected patients virologically suppressed with triple highly active antiretroviral therapy (haart) (anrs 167 lamidol)

Conditions: HIV-1 Infection

Summary: the principal objective is to evaluate the antiviral efficacy of 48 weeks treatment with the two-drugs combination dolutegravir(tivicay®) and lamivudine(tepivir®) in hiv-1 infected patients virologically suppressed with triple haart.

secondary objectives: the following parameters will be evaluated : * evolution of cd4 cells and cd8 cells * tolerance to treatment * emergence of resistance mutations at time of virological failure * hiv viral load measured with ultrasensitive assay (threshold 1 copy/ml) at day 0, week 8, week 32 and week 56 * influence of total dna at day 0 on the occurrence of virological failure or blip * plasma levels of dolutegravir(tivicay®) and lamivudine in participants with virological failure * adherence to treatment * quality of life * medico-economic aspects * dolutegravir(tivicay®) and nucleosidic reverse transcriptase inhibitors (nrtis) levels, and hiv viral load in semen in a subgroup of 20 participants. methodology: pilot trial, multicentric, national, prospective, no randomized and no comparative.

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.

Keywords: dolutegravir(tivicay®) lamivudine(epivir®) hiv-1 efficacy safety