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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EFV and Fixed combinations of analogues | Active Comparator | EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine |
|
| LPV/r and combination of analogues. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFV | Drug | one pill QD VO. |
| |
| LPV/r |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in limb fat mass measured by DEXA. | 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de Bellvitge | L'Hospitalet de Llobregat | Barcelona | Spain | |||
| Hospital Universitario Central de Asturias |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27089862 | Derived | Rojas J, Lonca M, Imaz A, Estrada V, Asensi V, Miralles C, Domingo P, Montero M, del Rio L, Fontdevila J, Perez I, Cruceta A, Gatell JM, Arnedo M, Martinez E. Improvement of lipoatrophy by switching from efavirenz to lopinavir/ritonavir. HIV Med. 2016 May;17(5):340-9. doi: 10.1111/hiv.12314. Epub 2015 Sep 10. |
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| Drug |
2 pills QD VO |
|
| Asturias |
| Spain |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital de la Santa Creu i Sant Pau de Barcelona | Barcelona | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital La Fe | Valencia | Spain |
| Hospital Xeral-Cíes | Vigo | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D008060 | Lipodystrophy |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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