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

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Juan A. Arnaiz
• Treatments: Efavirenz

Criteria

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.