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

Phase 4

Completed

• Conditions: HIV Infections; Lipoatrophy
• Interventions: Drug: EFV; Drug: LPV/r

• Registration Number: NCT00978237
• Lead Sponsor: Juan A. Arnaiz

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Study Start: 2009-10
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EFV and Fixed combinations of analogues	EFV	EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
LPV/r and combination of analogues.	LPV/r	-

Primary Outcome Measures

Name	Time	Method
Absolute change in limb fat mass measured by DEXA.	24 months.

Trial Locations

Locations (7)

Hospital Xeral-Cíes; 🇪🇸 Vigo, Spain

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Asturias, Spain

Hospital de la Santa Creu i Sant Pau de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Bellvitge; 🇪🇸 L'Hospitalet de LLobregat, Barcelona, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain