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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Infections Lipoatrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EFV and Fixed combinations of analogues

EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine

Group Type ACTIVE_COMPARATOR

EFV

Intervention Type DRUG

one pill QD VO.

LPV/r and combination of analogues.

Group Type EXPERIMENTAL

LPV/r

Intervention Type DRUG

2 pills QD VO

Interventions

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EFV

one pill QD VO.

Intervention Type DRUG

LPV/r

2 pills QD VO

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No