Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues.

Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.

Inclusion Criteria:

• Patients HIV positive > 18 years.
• Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
• HIV-ARN < 50 copies/mL in the las six months.
• Clinically evident lipoatrophy (moderate or severe).
• Negative pregnancy test.
• Signed informed consent.

Exclusion Criteria:

• Evidence of failure or mutation to therapy with protease inhibitors.
• Patients that can not be treated with LPV/r.
• Mild lipoatrophy.
• History of alcoholism or drug addiction that discourages participation in the study.
• Pregnancy or breastfeeding.
• Documented current or 4 weeks prior opportunistic infection.
• Creatinin clearance < 60mL/min.
• Concomitant use of nephrotoxic drugs or immunosuppressants.
• Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
• Patients under treatment with other drugs in investigation.
• Acute hepatitis.
• Any other disease that discourages participation.