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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number: 2007-002698-29 |
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| Name | Class |
|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Hospital Universitari Joan XXIII de Tarragona. | OTHER |
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This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochondrial functioning and immune response in 50 naive HIV patients after 48 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Tenofovir (TDF) + emtricitabine (FTC) + efavirenz (EFV) |
|
| 2 | Active Comparator | Tenofovir (TDF) + emtricitabine (FTC) + lopinavir/ritonavir (LPV/RTV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir + emtricitabine + efavirenz | Drug | Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences) + Efavirenz 600 mg, (Sustiva, Bristol-Myers Squibb) once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in total cholesterol and HDL and LDL fractions | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29683854 | Derived | Leyes P, Cofan M, Gonzalez-Cordon A, de Lazzari E, Trabal J, Domingo P, Negredo E, Vidal F, Forga MT, Gatell JM, Ros E, Martinez E. Increased cholesterol absorption rather than synthesis is involved in boosted protease inhibitor-associated hypercholesterolaemia. AIDS. 2018 Jun 19;32(10):1309-1316. doi: 10.1097/QAD.0000000000001837. | |
| 25155608 |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| D000068679 | Emtricitabine |
| C098320 | efavirenz |
| D061466 | Lopinavir |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Hospitales Universitarios Virgen del Rocío |
| OTHER |
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| Tenofovir + emtricitabine + lopinavir/ritonavir | Drug | Tenofovir 300 mg + emtricitabine 200 mg, (Truvada, Gilead Sciences)QD Lopinavir/ritonavir 400 mg/100 mg, (Kaletra, Abbott) BID |
|
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital Joan XXIII | Tarragona | Tarragona | 43007 | Spain |
| Egana-Gorrono L, Martinez E, Domingo P, Lonca M, Escriba T, Fontdevila J, Vidal F, Negredo E, Gatell JM, Arnedo M. Differential subcutaneous adipose tissue gene expression patterns in a randomized clinical trial of efavirenz or lopinavir-ritonavir in antiretroviral-naive patients. Antimicrob Agents Chemother. 2014 Nov;58(11):6717-23. doi: 10.1128/AAC.03481-14. Epub 2014 Aug 25. |
| 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 |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011744 | Pyrimidinones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |