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

NCT00978237 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-09-18

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Lipoatrophy

Interventions

DRUG

EFV

one pill QD VO.

DRUG

LPV/r

2 pills QD VO

Sponsors & Collaborators

  • Juan A. Arnaiz

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00978237 on ClinicalTrials.gov