E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 Infection |
Infección por VIH-1 |
|
E.1.1.1 | Medical condition in easily understood language |
HIV-1 Infection |
Infección por VIH-1 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10020161 |
E.1.2 | Term | HIV infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the lipidómic profile of patients with HIV -1 viral suppression changing efavirenz + emtricitabine + tenofovir ( Atripla) to rilpivirine + emtricitabine + tenofovir ( Eviplera® ) versus a group of patients who continue to Atripla after 12 weeks from the switch |
Comparar el perfil lipidómico de pacientes con infección por el VIH-1 con supresión virológica que cambian de efavirenz + emtricitabina + tenofovir (Atripla®) a rilpivirina + emtricitabina + tenofovir (Eviplera®) versus un grupo de pacientes que continúan con Atripla® 12 semanas después del cambio |
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E.2.2 | Secondary objectives of the trial |
- To compare the lipidomics profile of maintaining Atripla® versus switching to Eviplera® at study week 24 - To compare for both groups the lipidomics profile at study week 24 with what is already known about liver steatosis lipidomics in uninfected patients - (Owliver, http://www.ncbi.nlm.nih.gov/pubmed/22364559 ) - To correlate lipidomic parameters with changes on lipid parameters used in clinical practice (total cholesterol, HDL, LDL, triglycerides, apolipoprotein AI and apolipoprotein B) and insulin resistance (HOMA-IR) - To assess inmuno-virology (CD4+ cell, CD8+ and viral load) after the switch at week 4, 12 and 24 of treatment. - To evaluate clinical safety at study week 4,12 and 24 in both treatment groups |
- Comparar el perfil lipidómico de pacientes con infección por el VIH-1 con supresión virológica que cambian de Atripla® a Eviplera® versus un grupo de pacientes que continúan con Atripla® 24 semanas después del cambio. - Comparar los resultados obtenidos en el estudio de lipidómica en ambos grupos con las alteraciones observadas en estudios previos en pacientes sin infección por el VIH con esteatosis hepática tras 24 semanas (plataforma OWLiver: http://www.ncbi.nlm.nih.gov/pubmed/22364559). - Correlacionar los parámetros de lipidómica con los cambios en los parámetros utilizados en la práctica clínica para el metabolismo lipídico (colesterol total, HDL, LDL, triglicéridos, apolipoproteína AI y apolipoproteína B) y la resistencia a la insulina (HOMA-IR). - Evaluación inmuno-virológica tras el cambio (linfocitos CD4+, linfocitos CD8+ y carga viral VIH), a las semanas 4,12 y 24. - Evaluación de la seguridad clínica a las semanas 4,12 y 24 en ambos grupos de pacientes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients aged 18 years or above - Patients infected with HIV-1 - Patients in treatment with Atripla for at least the last six months. - Patients with virologic suppression ( RNA -HIV <50 copies / ml ) for at least the last six months . - Fertile Women must use a double barrier contraceptive method - Voluntary signature of the informed consent |
- Pacientes de edad igual o superior a 18 años - Pacientes infectados por VIH-1 - Pacientes en tratamiento con Atripla® al menos durante los últimos 6 meses. - Pacientes con supresión virológica ( ARN-VIH < 50 cop/ml) al menos durante los últimos 6 meses. - Mujeres en edad fértil deben utilizar un método anticonceptivo de doble barrera. - Firma voluntaria del consentimiento informado |
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E.4 | Principal exclusion criteria |
- Any acute or chronic disease (besides the chronic infection for HIV 1) that could interfere in the lipidomic analysis - Pregnant or nursing women - Abuse of alcohol or other drugs - BMI > 25 - Use of drugs that may affect lipid metabolism ( lipid lowering drugs , steroids ... ) - Patients unable to understand the protocol of the study or any other condition that in opinion of the investigator could compromise the fulfillment of the protocol - History or presence of allergy to any of the study drugs or their components |
- Cualquier enfermedad aguda o crónica (además de la infección crónica por VIH-1) que pueda interferir en el análisis de lipidómica - Mujer embaraza o en periodo de lactancia - Abuso de alcohol u otras drogas - IMC>25 - Uso de fármacos que puedan afectar al metabolismo lipídico (hipolipemiantes, esteroides?) - Pacientes incapaces de entender el protocolo del estudio o cualquier otra condición que en opinión del investigador pueda comprometer el cumplimiento del protocolo - Historia o presencia de alergia a alguno de los fármacos del estudio o a sus componentes |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in plasma lipid profile measured by lipidomic in patients with chronic HIV -1 antiretroviral therapy and viral suppression |
Cambios en el perfil lipídico en plasma medido por lipidómica en pacientes con infección crónica por el VIH-1 en tratamiento antirretroviral y supresión virológica. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Related to HIV infection: CD4 + lymphocytes , CD8 + lymphocytes, HIV viral load - Related lipid profile : total cholesterol, HDL , LDL , triglycerides, apolipoproteins . - Related to glucose metabolism : glucose, insulin. - Related to the liver : liver function - Related to the safety: adverse events that could appear. - Relative to the adherence: drug accoutability |
- Relativas a infección por VIH: linfocitos CD4+, linfocitos CD8+, carga viral VIH. - Relativas al perfil lipídico: colesterol total, HDL, LDL, triglicéridos, apolipoproteínas. - Relativas al metabolismo glucosa: glucemia, insulina. - Relativas al hígado: función hepática. - Relativas a la seguridad: acontecimientos adversos que puedan aparecer. - Relativas a la adherencia: recuento de comprimidos. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Depending on the endpoint the timepoint will be different: Weeks 4, 12 and 24 |
Dependiendo de la variable, el momento de evaluación puede ser diferente: Semanas 4, 12 y 24 del estudio |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS included |
NVLS incluido |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |