Randomized, open-label, non-inferiority clinical trial with 96-week follow-up on the efficacy of azatanavir/ritonavir + lamivudine as maintenance therapy in patients with viral load suppression

INTERVENTION: Trade Name: REYATAZ 300 mg hard capsules Pharmaceutical Form: Capsule, hard INN or Proposed INN: ATAZANAVIR Other descriptive name: ATAZANAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Ritonavir Product Name: RITONAVIR Pharmaceutical Form: Capsule, soft INN or Proposed INN: RITONAVIR Other descriptive name: RITONAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Ritonavir Product Name: RITONAVIR Pharmaceutical Form: Tablet INN or Proposed INN: RITONAVIR Other descriptive name: RITONAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Lamivudine Product Name: LAMIVUDINA Pharmaceutical Form: Tablet INN or Proposed INN: LAMIVUDINA CAS Number: LAMIVUDINA Other descriptive name: LAMIVUDINA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: REYATAZ 300 mg hard capsules Product Name: Reyataz Pharmaceutical Form: Capsule, hard INN or Proposed INN: ATAZANAVIR Other descriptive name: ATAZANAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300‐ Trade Name: Ritonavir Product Name: RITONAVIR Pharmaceutical Form: Capsule, soft INN or Proposed INN: RITONAVIR Other descriptive name: RITONAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Ritonavir Product Name: RITONAVIR Pharmaceutical Form: Tablet INN or Proposed INN: RITONAVIR Other Descriptive name: RITONAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100‐ Trade Name: Nucleoside Reverse Transcriptase Inhibitors Product Name: NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Pharmaceutical Form: Capsule INN or Proposed INN: NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Other descriptive name: NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS Concentration u CONDITION: Chronic HIV-1 infection. MedDRA version: 14.0 Level: LLT Classification code 10001509 Term: AIDS System Organ Class: 10021881 - Infections and infestations Therapeutic area: Diseases [C] - Virus Diseases [C02] PRIMARY OUTCOME: Main Objective: The primary objective is to evaluate the non-inferiority of maintenance therapy with atazanavir/ritonavir+lamivudine versus atazanavir/ritonavir+2 optimized nucleos(t)ides, at 48 weeks after the start of treatment, in patients with sustained HIV viral load suppression who change treatment due to toxicity, intolerance, or simplification. Primary endpoint(s): The primary endpoint is the proportion of patients with undetectable viral load (<50 copies/ml) at 48 weeks of follow-up, according to the TLOVR40 algorithm in the per-protocol population. Secondary Objective: To compare the efficacy of the study regimen versus the control regimen at 24 and 96 weeks; to evaluate the safety and tolerability of the study and control regimens; to evaluate the incidence and type of resistance mutations that appear in patients with virological failure. Timepoint(s) of evaluation of this endpoint: 48 weeks SECONDARY OUTCOME: Secondary endpoint(s): Proportion of patients with viral load <50 copies/ml at weeks 24 and 96 (in the per-protocol population, according to the TLOVR algorithm and considering losses and changes = failures); Proportion of patients with viral load <400 copies/ml at weeks 24 and 96 (in the per-protocol population, according to the TLOVR algorithm and considering losses and changes = failures). Proportion of patients with viral load <50 copies/ml at weeks 24 and 96 (in the intention-to-treat population, according to the TLOVR algorithm and considering losses and changes = treatment failures).; Proportion of patients with viral load <50 copies/ml at weeks 24 and 96 (in the intention-to-treat population, according to the TLOVR algorithm and considering only losses = treatment failures).; Proportion of patients with viral load <50 copies/ml or <400 copies/ml at weeks 24 and 96 in the treatment population.; Proportion of patients with detectable viremia (50 or 400 copies/ml) at weeks 24, 48, and 96.; Proportion of patients with viral load <50 copies/ml at weeks 48 and 96 according to HIV-1 subtype (treatment population). Changes in CD4/L lymphocyte count, compared to baseline, at weeks 24, 48, and 96. Timepoint(s) of evaluation of this endpoint: Weeks 24, 48, and 96 INCLUSION CRITERIA: Patients capable of giving their informed consent to participate in the study (preferably in writing or, failing that, orally in the presence of witnesses independent of the research team) after having received information about the design, the purposes of the study, the possible risks that may arise from it, and the possibility of withdrawing from it at any time. Participants must understand the purpose of the study and be available for the visits stipulated in the protocol. They must be 18 years of age or older. They must have chronic HIV-1 infection. Patients must be on their first antiretroviral therapy (ART) regimen consisting of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third drug for at least one year prior to enrollment. Changes to any component of this ART regimen are permitted provided they occurred within the four months prior to enrollment and are not due to virological failure. Viral load must be undetectable for at least six months.