Randomized, controlled, multicentric trial to evaluate efficacy and safety of the switch from a LPV/r based therapy to an ATV/r or a NVP based treatment in association with ABC/3TC, in HIV patient with undetectable viral load

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2007
INTERVENTION: Trade Name: VIRAMUNE*60CPR 200MG Pharmaceutical Form: Tablet INN or Proposed INN: Nevirapine Concentration unit: mg milligram(s) Concentration number: 200‐ Trade Name: REYATAZ*60CPS 150MG Pharmaceutical Form: Capsule, hard INN or Proposed INN: Atazanavir Concentration unit: mg milligram(s) Concentration number: 150‐ Trade Name: KIVEXA*BL 30CPR RIV 600MG+300M Pharmaceutical Form: Coated tablet INN or Proposed INN: Combinations Concentration unit: mg milligram(s) Concentration number: 600‐ Trade Name: NORVIR*4FL 84CPS MOLLI 100MG Pharmaceutical Form: Capsule, soft INN or Proposed INN: Ritonavir Concentration unit: mg milligram(s) Concentration number: 100‐ Trade Name: KALETRA*BLIST 180CPS MOLLI Pharmaceutical Form: Capsule, soft INN or Proposed INN: Protease inhibitors Concentration unit: mg milligram(s) Concentration number: 200‐ CONDITION: HIV infection ; 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: To compare the different incidence of virologic failure between the two groups after 12 months from randomization. Primary end point(s): ? Proportion of patients with HIV pVL <50 copies/ml in the two different groups. Secondary Objective: ? To evaluate after 12 months any changes of CD4+ and CD8+ (absolute value and percentage);; ? To evaluate after 12 months any metabolic, morphologic lipodystrophic alteration;; ? To evaluate after 12 months the alteration of the bone metabolism INCLUSION CRITERIA: ? Male and female subjects between 18 and 65 years of age inclusive; ? Informed consent ; ? HIV‐1 infected patients ; ? Actual treatment with a first/second line HAART with LPV/r and 2 NRTI longer than 6 months; ? Viral load suppression (HIV‐1 <50 copies/ml) for at least 6 months before entry the study; ? Any CD4 count with the exception of women with more than 250 CD4/ml; ? Stable clinical conditions. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 8683f9f2febe2a18eaa2443ab085ff2476847bc5
First added on: Aug 21, 2024