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The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor
The Study will help to compare the Quality of Life for those HIV patients that are on monotherapy with LPV/r Vs. triple therapy with a boosted protease inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple therapy | Active Comparator | The patients who would be allocated to this arm will continue with their triple therapy treatment, based on any protease inhibitor boosted with ritonavir |
|
| Monotherapy | Experimental | Those patients allocated to this arm will start to take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lopinavir and ritonavir | Drug | The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life comparison for HIV patients that start monotherapy with lopinavir/ritonavir (LPV/r) tablets vs patients with triple therapy which would include any boosted protease inhibitor (PI). | 24 weeks per patients |
| Measure | Description | Time Frame |
|---|---|---|
| Virologic efficacy assessment for HIV patients on monotherapy based on LPV/r tablet vs triple therapy which would include any protease inhibitor | 24 weeks per patient | |
| Immune response changes assessment for those HIV patients who start monotherapy with LPV/r tablets vs HIV patients on triple therapy which would include any protease inhibitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Pasquau, MD | Sociedad Andaluza de Enfermedades Infecciosas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de San Juan | San Juan | Alicante | 03550 | Spain | ||
| Hospital de Torrevieja |
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| Triple therapy with ritonavir | Drug | The patients will continue to take their usual triple therapy, as established in the summary of product characteristics |
|
| 24 weeks per patients |
| Patient satisfaction assessment for HIV patients that start monotherapy with LPV/r tablets vs triple therapy which would include any protease inhibitor | 24 weeks per patient |
| Treatment adherence assessment for HIV patients who start on LPV/r monotherapy tablets vs triple therapy which include any protease inhibitor | 24 weeks per patient |
| Tolerability and safety assessment for the HIV patients who start monotherapy treatment with LPV/r tablets vs triple therapy which would include any protease inhibitor | 24 weeks |
| Torrevieja |
| Alicante |
| 03186 |
| Spain |
| Hospital de Villajoyosa | Villajoyosa | Alicante | 03570 | Spain |
| Hospital de Torrecárdenas | Almería | Almería | 04009 | Spain |
| Hospital General de l'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08906 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital General Yagüe | Burgos | Burgos | 09005 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Puerta del Mar | Cadiz | Cádiz | 11009 | Spain |
| Hospital Puerto Real | Cadiz | Cádiz | 11510 | Spain |
| Hospital Clínico San Cecilio | Granada | Granada | 18012 | Spain |
| Hospital Virgen de las Nieves | Granada | Granada | 18014 | Spain |
| Pilar Vázquez Rodríguez | A Coruña | La Coruña | 15006 | Spain |
| Hospital Clínico Santiago de Compostela | Santiago de Compostela | La Coruña | 15706 | Spain |
| Hospital Dr. Negrín | Las Palmas de Gran Canaria | Las Palmas | 35010 | Spain |
| Hospital Severo Ochoa | Leganés | Madrid | 28911 | Spain |
| Hospital Universitario de La Princesa | Madrid | Madrid | 28006 | Spain |
| Hospital Gregorio Marañón | Madrid | Madrid | 28007 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Carlos Haya | Málaga | Málaga | 29010 | Spain |
| Hospital Clínico de Málaga | Málaga | Málaga | 29010 | Spain |
| Hospital Universitario de Canarias | Santa Cruz de Tenerife | Santa Cruz de Tenerife | 38320 | Spain |
| Hospital de Valme | Seville | Sevilla | 41014 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | 41071 | Spain |
| Hospital Virgen de la Cinta | Tortosa | Tarragona | 43500 | Spain |
| Hospital Clínico de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital Arnau de Vilanova | Valencia | Valencia | 46015 | Spain |
| Hospital de Cruces | Barakaldo | Vizcaya | 48904 | Spain |
| Hospital de Basurto | Basurto | Vizcaya | 48013 | Spain |
| Hospital Clínico Lozano Blesa | Zaragoza | Zaragoza | 50009 | Spain |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| 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 |
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| ID | Term |
|---|---|
| C558899 | lopinavir-ritonavir drug combination |
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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