Clinical trial to evaluate the effect on subcutaneous fat of switching from EFV to LPV/r in HIV-infected patients who developed lipoatrophy that remains clinically evident despite treatment with efavirenz and a fixed-dose combination of non-thymidine nucleoside analogues

INTERVENTION: Trade Name: KALETRA 133,3/33,3 mg cápsulas blandas Pharmaceutical Form: Capsule, soft INN or Proposed INN LOPINAVIR Other descriptive name: LOPINAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 133.3‐ INN or Proposed INN RITONAVIR Other descriptive name: RITONAVIR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 33.3‐ Trade Name: SUSTIVA 600 mg comprimidos recubiertos con película Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: EFAVIRENZ CAS Number: 154598‐52‐4 Other descriptive name: EFAVIRENZ Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Primary endpoint(s): Absolute change in limb fat mass (measured by DEXA) at 24 months compared to baseline in both treatment groups. Secondary objectives: To evaluate the absolute change in limb fat mass at 12 months compared to baseline in both study arms; To evaluate the absolute change in limb fat mass (measured by DEXA) at 12 months compared to baseline in both treatment groups; To evaluate the relative (percentage) change in limb fat mass at 12 and 24 months after the start of the study; To evaluate the change in the clinical assessment of lipoatrophy at 12 and 24 months. Evaluate at 12 and 24 months whether there are changes in intra-abdominal fat (measured by CT scan); Evaluate at 12 and 24 months whether there are changes in weight; Evaluate at 12 and 24 months whether there are changes in the lipid profile (triglycerides, total cholesterol, LDL cholesterol, and HDL cholesterol) and in insulin resistance parameters (HOMA); Evaluate at 12 and 24 months the proportion of patients with a virological response (HIV RNA <50 copies/mL); Evaluate the inclusion profile at 12 and 24 months. CRITERIA: - Patients aged ≥ 18 years infected with HIV-1, documented by a positive HIV-1 antibody test and/or positive PCR confirmed for HIV-1 RNA. - Patients on treatment with Sustiva® + Truvada® or Sustiva® + Kivexa®. - Patients with an undetectable viral load defined as HIV-RNA < 50 copies/mL in the last 6 months. - Patients with evidence of moderate or severe clinical lipoatrophy. - For women of childbearing age, a negative urine pregnancy test at the screening visit. - Patients who have provided written informed consent before undergoing any study-specific screening procedures. Are the trial subjects under 18? no Number of subjects for this age range: 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) yes F.1.3.1 Number of subjects for this age range