E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HIV-1 infected solid organ transplant patients |
pacientes trasplantados de órganos sólidos infectados por el VIH-1. |
|
E.1.1.1 | Medical condition in easily understood language |
HIV-1 infected solid organ transplant patients |
pacientes trasplantados de órganos sólidos infectados por el VIH-1. |
|
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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10068341 |
E.1.2 | Term | HIV-1 infection |
E.1.2 | System Organ Class | 100000004862 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057925 |
E.1.2 | Term | Transplant evaluation |
E.1.2 | System Organ Class | 10022891 - Investigations |
|
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 |
The aims of this study are to obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients To provide proof of principle data that DTG plus 2 NUCs is safe and effective in HIV‐infected SOT recipients. |
1: Obtener datos farmacocinéticos sobre las interacciones entre DTG y fármacos inmunosupresores (ciclosporina A, Tacrolimus, Syrolimus y ácido micofenólico) en receptores de trasplante de órgano sólido (SOT en sus siglas inglesas) y 2. Proporcionar una prueba de concepto de que la pauta antirretroviral de DTG más 2 NNRTIs es segura y eficaz en paciente infectados por el VIH receptores de un SOT. |
|
E.2.2 | Secondary objectives of the trial |
1. To assess the development of viral resistance in subjects experiencing virological failure;
2. To assess the changes in CD4+ cell count in peripheral blood;
3. To assess the changes in lipid profile (triglycerides, total, LDL‐ and HDL‐cholesterol);
4. To assess renal function in HIV SOT patients. |
1. Evaluar el desarrollo de resistencia viral en sujetos con fracaso virológico; 2. Evaluar los cambios en el recuento de células CD4 + en la sangre periférica; 3. Evaluar los cambios en el perfil lipídico (triglicéridos, colesterol total, LDL y HDL); 4. Evaluar la función renal en pacientes con SOT VIH. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetic (PK) studies v1.0_ 08_may_2017 The aim is to detect any possible drug‐drug interactions between DTG and widely‐used immunosuppressant drugs (IS) (Cyclosporine A , Tacrolimus, Syrolimus and Mycophenolic acid). |
estudio Farmacocinético PK) studies v1.0_ 08_may_2017 El objetivo es detectar cualquier posible interacción fármaco-fármaco entre DTG y fármacos inmunosupresores ampliamente utilizados (ciclosporina A, tacrolimus, sirolimus y ácido micofenólico). |
|
E.3 | Principal inclusion criteria |
1. HIV patients >18 years old who provide signed and dated informed consent; 2. Males and females; 3. SOT recipients (heart, liver or kidney); 4. On stable ART for ≥6 months preceding the screening visit; 5. Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations); 6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing |
1. Pacientes VIH> 18 años de edad que proporcionan consentimiento informado firmado y fechado; 2. Hombres y mujeres; 3. receptores de SOT (corazón, hígado o riñón); 4. Sobre ART estable durante ≥6 meses antes de la visita de cribado; 5. ARN del VIH plasmático <50 cop / ml durante 12 meses (2 pruebas separadas por al menos 12 meses sin carga viral> 50 entre determinaciones); 6. Ausencia de importantes mutaciones del gen de la transcriptasa inversa o de la integrasa que afectan la eficacia del fármaco del estudio mediante la secuenciación del ADN proviral. |
|
E.4 | Principal exclusion criteria |
1. HIV patients who have stopped ART due to virological failure; 2. HIV patients who require treatment with DTG contraindicated medications; 3. History or presence of an allergy or intolerance to the study drug; 4. Active opportunistic infection; 5. Neoplasms requiring chemotherapy. 6. Pregnancy or breast feeding or planned pregnancy during the study period 7. Any other contraindication to study drugs. |
1. Pacientes con VIH que han dejado el TAR debido a fallo virológico; 2. Pacientes con VIH que requieren tratamiento con medicamentos contraindicados por DTG; 3. Antecedentes o presencia de una alergia o intolerancia al fármaco del estudio; 4. Infección oportunista activa; 5. Neoplasias que requieren quimioterapia; 6. Cualquier otra contraindicación para estudiar drogas. 7. Mujeres embarazadas o intención de embarazo durante el estudio. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. To obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients;
2. To provide proof of principle data that DTG plus 2 NRTIs is safe and effective in HIV‐infected SOT recipients. (numer AES, SAEs related treatment and CD4 cels |
1: Obtener datos farmacocinéticos sobre las interacciones entre DTG y fármacos inmunosupresores (ciclosporina A, Tacrolimus, Syrolimus y ácido micofenólico) en receptores de trasplante de órgano sólido (SOT en sus siglas inglesas) y 2. Proporcionar una prueba de concepto de que la pauta antirretroviral de DTG más 2 NNRTIs es segura y eficaz en paciente infectados por el VIH receptores de un SOT. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid)
Susars, SAEs, Death |
Intweracciones del dolutegravir con tratamientos inmuodepresores ( Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid)
Susars, SAEs, muerte |
|
E.5.2 | Secondary end point(s) |
To assess the development of viral resistance in subjects experiencing virological failure;
2. To assess the changes in CD4+ cell count in peripheral blood;w 48
3. To assess the changes in lipid profile (triglycerides, total, LDL‐ and HDL‐cholesterol); w 48
4. To assess renal function in HIV SOT patients.w 48 |
. Evaluar el desarrollo de resistencia viral en sujetos con fracaso virológico;sem 48 2. Evaluar los cambios en el recuento de células CD4 + en la sangre periférica;sem 48 3. Evaluar los cambios en el perfil lipídico (triglicéridos, colesterol total, LDL y HDL);s 48 4. Evaluar la función renal en pacientes con SOT VIH.sem 48 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
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 | No |
E.8.1.1 | Randomised | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |