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

Study Overview
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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.

Official Title
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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.

Conditions
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HIV Infections, Lipoatrophy

Intervention / Treatment
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* Drug: EFV
* Drug: LPV/r


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EFV and Fixed combinations of analogues<br>EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine | Drug: EFV<br>* one pill QD VO.<br>|
| Experimental: LPV/r and combination of analogues.<br> | Drug: LPV/r<br>* 2 pills QD VO<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in limb fat mass measured by DEXA. |  | 24 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV - Lipoatrophy, treatment experienced