E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Human immunodeficiency virus type 1 (HIV-1) |
Virus de la inmunodeficiencia humana tipo 1 (VIH-1) |
|
E.1.1.1 | Medical condition in easily understood language |
Human immunodeficiency virus type 1 (HIV-1) |
Virus de la inmunodeficiencia humana tipo 1 (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 | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003582 |
E.1.2 | Term | Asymptomatic human immunodeficiency virus type I infection |
E.1.2 | System Organ Class | 100000004862 |
|
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 demonstrate the non-inferior antiviral activity of switching to dolutegravir (DTG) plus rilpivirine (RPV) once daily compared to continuation of current antiretroviral regimen (CAR) over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced subjects |
Demostrar la no inferioridad de la actividad antiviral del cambio a
dolutegravir (DTG) más rilpivirina (RPV) una vez al día en comparación
con el tratamiento antirretroviral actual (TARA) durante 48 semanas en
sujetos infectados por VIH-1 que reciben tratamiento antirretroviral
(TAR). |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the immunological activity of DTG + RPV once daily
compared to continuation of CAR.
- To evaluate the antiviral activity of DTG + RPV once daily compared to
continuation of CAR.
- To evaluate the safety and tolerability of DTG + RPV once daily
compared to continuation of CAR over time.
- To evaluate renal (in urine and blood), bone (in blood), and
cardiovascular biomarkers (in blood) in subjects treated with DTG + RPV
compared to continuation of CAR.
- To evaluate the effects of DTG + RPV once daily on fasting lipids over
time compared to continuation of CAR.
- To assess viral resistance in subjects meeting Virologic Withdrawal
Criteria.
- To evaluate DTG and RPV trough concentrations.
- To evaluate the DTG and RPV trough concentrations over time during
the initial post-switch period in the first 20 subjects in the NNRTI Subset who switch from EFV or NVP to DTG + RPV.
REFER TO PROTOCOL (page 18, section3) FOR COMPLETE LIST
SECONDARY OBJECTIVES. |
- Evaluar la actividad inmunológica de DTG + RPV una vez al día en
comparación con el TARA
- Evaluar la actividad antiviral de DTG + RPV una vez al día en
comparación con el TARA
- Evaluar la seguridad y tolerabilidad de DTG + RPV una vez al día en
comparación con la continuación del TARA a lo largo del tiempo
- Evaluar los biomarcadores renales (en orina y sangre), óseos (en
sangre) y cardiovasculares (en sangre) en sujetos tratados con DTG +
RPV en comparación con la continuación del TARA
- Evaluar los efectos de DTG + RPV una vez al día en los lípidos en
ayunas a lo largo del tiempo en comparación con la continuación del
TARA
- Evaluar la resistencia viral en sujetos que cumplan los criterios de
Retirada por Confirmación Virológica
- Evaluar las concentraciones mínimas de DTG y RPV .
Ver Sección 3 del Protocolo para una lista completa de los Objetivos
Secundarios. |
|
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 |
Title: Genetic Research, 26-FEB-2015, version 01 (2014N208737_01)
The objectives of the genetic research are to investigate a relationship
between genetic variants and:
- Response to medicine, including DTG + RPV or any concomitant
medicines;
- HIV-1 susceptibility, severity and progression and related conditions.
Title: An evaluation of bone mineral density in HIV-1-infected adult
subjects switching from a tenofovir-containing antiretroviral therapy
regimen to a dolutegravir plus rilpivirine regimen
11-MAR-2015, Version 0 (2014N221875_00)
Primary Objective: To evaluate the change in BMD assessed by areal
density in total hip at 48 weeks following switch of subjects from an ART
regimen containing TDF to DTG + RPV once daily compared to continued
therapy with the TDF-containing regimen |
|
E.3 | Principal inclusion criteria |
Eligible subjects must:
- be able to understand and comply with protocol requirements,
instructions, and restrictions;
- be likely to complete the study as planned;
- be considered appropriate candidates for participation in an
investigative clinical trial with oral medication (e.g., no active substance
abuse, acute major organ disease, or planned long-term work
assignments out of the country, etc.).
Subjects eligible for enrollment in the study must meet all of the
following criteria:
1. HIV-1 infected men or women ≥18 years of age;
2. Must be on uninterrupted current regimen (either the initial or second
cART regimen) for at least 6 months prior to Screening Any prior switch
to a second cART regimen, defined as a change of a single drug or
multiple drugs simultaneously, must have occurred due to tolerability and/or safety concerns or access to medications, or
convenience/simplification.
Acceptable stable cART regimens prior to Screening include 2 NRTIs
plus:
- INI (either the initial or second cART regimen)
- NNRTI (either the initial or second cART regimen)
- Boosted PI (or atazanavir [ATV] unboosted) (must be initial cART
regimen; one within class switch permitted for tolerability);
3. Documented evidence of at least two plasma HIV-1 RNA
measurements <50 c/mL in the 12 months prior to Screening: one
within the 6 to 12 month window, and one within 6 months prior to
Screening;
4. Plasma HIV-1 RNA <50 c/mL at Screening;
5. A female, may be eligible to enter and participate in the study if she:
a. is of non-child-bearing potential either defined as post-menopausal
(12 months of spontaneous amenorrhea and ≥45 years of age) or
physically incapable of becoming pregnant with documented tubal
ligation, hysterectomy or bilateral oophorectomy or,
b. is of child-bearing potential with a negative pregnancy test at both
Screening and Day 1 and agrees to use one of the following methods of
contraception to avoid pregnancy:
- Complete abstinence from intercourse from 2 weeks prior to
administration of IP, throughout the study, and for at least 2 weeks after
discontinuation of all study medications;
- Male condom/spermicide, male
condom/diaphragm,diaphragm/spermicide;
- Any intrauterine device (IUD) with published data showing that the
expected failure rate is <1% per year (not all IUDs meet this criterion,
see the SPM for a listing describing criteria of approved IUDs);
- Male partner sterilization prior to the female subject's entry into the
study and this male is the sole partner for that subject;
- Approved hormonal contraception for subjects randomly assigned to
DTG + RPV arm or approved hormonal contraception plus a barrier
method for subjects assigned to CAR (see the SPM for a listing of
examples of approved hormonal contraception);
- Any other method with published data showing that the expected
failure rate is <1% per year.
Any contraception method must be used consistently, in accordance with
the approved product label during treatment with IP and for at least 2
weeks after discontinuation of study drug. All subjects participating in
the study should be counseled on safer sexual practices including the
use and benefit/risk of effective barrier methods (e.g., male condom)
and on the risk of HIV transmission to an uninfected partner.
6. Subject is willing and able to understand requirements of study
participation and provide signed and dated written informed consent
prior to Screening.
7. For subjects enrolled in France: a subject will be eligible for inclusion
in this study only if either affiliated to or a beneficiary of a social security
category. |
Los sujetos elegibles deben:
- ser capaces de comprender y cumplir con los requisitos, instrucciones y
restricciones del protocolo;
- tener las probabilidades de completar el estudio según lo previsto;
- ser considerados como candidatos apropiados para participar en un
ensayo clínico de investigación con fármacos orales (p. ej. sin abuso de
sustancias activas, enfermedad orgánica importante aguda o
asignaciones laborales planificadas a largo plazo fuera del país, etc.).
Los sujetos elegibles para su inclusión en el estudio deben cumplir todos
los criterios que se enumeran a continuación:
1. Mujeres o varones infectados por VIH-1 ≥ 18 años de edad; 2. Deben haber recibido el tratamiento actual de forma ininterrumpida
(el inicial o el segundo TARc) durante, al menos, 6 meses previos a la
Selección; Cualquier modificación previa al segundo TARc, definido como
el cambio de un único fármaco o diversos fármacos de manera
simultánea, se debe realizar por problemas de tolerabilidad y/o
seguridad o acceso a los fármacos o por comodidad/simplificación.
Los TARc estables aceptables antes de la Selección incluyen 2 ITIN más:
- IIn (el inicial o el segundo TARc)
- ITINN (el inicial o el segundo TARc)
- IP potenciado (o atazanavir [ATV] no potenciado) (debe ser el TARc
inicial; uno en el cambio de clase permitido por tolerabilidad)
3. Evidencia documentada de, al menos, dos determinaciones del ARN
del VIH-1 en plasma < 50 c/ml en los 12 meses antes de la Selección:
una en la ventana de 6 a 12 meses y otra en los 6 meses previos a la
Selección;
4. ARN del VIH-1 en plasma < 50 c/ml en la Selección;
5. Una mujer es elegible para formar parte del estudio si:
a. no está en edad fértil por encontrarse en periodo posmenopáusico (12
meses de amenorrea espontánea y ≥ 45 años de edad) o son físicamente
incapaces de quedarse embarazada con ligadura de trompas,
histerectomía u ooforectomía bilateral documentadas o bien;
b. está en edad fértil y presenta prueba de embarazo negativa durante la
Selección y el Día 1 y acepta utilizar los métodos anticonceptivos
apropiados que se citan a continuación para evitar el embarazo:
- Abstinencia completa de relaciones sexuales desde dos semanas antes
de la administración del PEI, a lo largo del estudio y hasta, al menos, dos
semanas después de la interrupción de todos los fármacos del estudio.
- Condón masculino/espermicida, preservativo masculino/diafragma,
diafragma/espermicida.
- Cualquier dispositivo intrauterino (DIU) con datos publicados que
demuestren que la tasa de fracasos prevista es < 1% al año (no todos
los DIU satisfacen este criterio, véase en el MPE para un listado en el que
se describen los criterios de los DIU autorizados).
- Esterilización de la pareja masculina antes de la inclusión de la
paciente en el estudio y dicho varón es la única pareja del sujeto.
- Anticonceptivos hormonales autorizados para sujetos aleatorizados al
brazo con DTG + RPV o anticonceptivos hormonales autorizados y un
método de barrera para sujetos asignados a recibir el TARA (véase el
MPE para una lista de ejemplos de anticonceptivos hormonales
autorizados).
- Cualquier otro método con datos publicados que respalden que la tasa
de fracasos prevista es < 1% al año.
Cualquier método anticonceptivo se debe utilizar de manera constante,
conforme a lo dispuesto en la ficha técnica del producto durante el
tratamiento con el PEI y, al menos, dos semanas tras la interrupción del
fármaco del estudio.
Todos los sujetos que participan en el estudio deben recibir
asesoramiento con respecto a prácticas sexuales más seguras tales
como el uso y los beneficios/riesgos de métodos de barrera eficaces (p.
ej. preservativo masculino) y sobre el riesgo de la transmisión del VIH a
la pareja no infectada.
6. El sujeto está dispuesto y es capaz de comprender los requisitos de la
participación en el estudio y proporciona el consentimiento informado
escrito con firma y fecha antes de la Selección.
7. Sujetos incluidos en Francia: únicamente los sujetos afiliados o
beneficiarios de una categoría de la Seguridad Social se considerarán
elegibles para la inclusión en este estudio. |
|
E.4 | Principal exclusion criteria |
A subject will not be eligible for inclusion in this study if any of the
following criteria apply:
Exclusionary Criteria prior to Screening or Day 1
1. Within 6 months prior to Screening and after confirmed suppression to
<50 c/mL on current ART regimen, any plasma HIV-1 RNA measurement
50 c/mL;
2. Within the 6 to 12 month window prior to Screening and after
confirmed suppression to <50 c/mL, any plasma HIV-1 RNA
measurement >200 c/mL;
3. Within the 6 to 12 month window prior to Screening and after
confirmed suppression to <50 c/mL, 2 or more plasma HIV-1 RNA
measurements 50 c/mL;
4. Any drug holiday during the window between initiating first HIV ART
and 6 months prior to Screening, except for brief periods (less than 1
month) where all ART was stopped due to tolerability and/or safety
concerns;
5. Any switch to a second line regimen, defined as change of a single
drug or multiple drugs simultaneously, due to virologic failure to therapy
(defined as a confirmed plasma HIV-1 RNA measurement > or = 400
c/mL after initial suppression to <50 c/mL while on first line HIV
therapy regimen);
Exclusionary medical conditions
6. Women who are pregnant, breastfeeding or plan to become pregnant
or breastfeed during the study;
7. Any evidence of an active Centers for Disease Control and Prevention
(CDC) Category C disease. Exceptions include cutaneous Kaposi's
sarcoma not requiring systemic therapy and historic CD4+ lymphocyte
counts of <200 cells/mm3;
8. Subjects with severe hepatic impairment (Class C) as determined by
Child-Pugh Classification C Appendix 2 of study Protocol, p98);
9. Unstable liver disease (as defined by the presence of any of the
following: ascites, encephalopathy, coagulopathy, hypoalbuminaemia,
oesophageal or gastric varices, or persistent jaundice), cirrhosis, known
biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones);
10. Evidence of Hepatitis B virus (HBV) infection based on the results of
testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core
antibody (anti-HBc), and antibodies against Hepatitis B surface antigen
(anti-HBsAg) as follows:
- Subjects positive for HBsAg are excluded;
- Subjects positive for anti-HBc (negative HBsAg status) and negative for
anti-HBsAg are excluded.
11. Subjects with an anticipated need for any Hepatitis C virus (HCV)
therapy during the Early Switch Phase and for interferon-based therapy
for HCV throughout the entire study period;
A subject will not be eligible for inclusion in this study if any of the
following criteria apply:
12. History or presence of allergy to the study drugs or their components
or drugs of their class;
13. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal
cell carcinoma, or resected, non-invasive cutaneous squamous cell
carcinoma, or cervical intraepithelial neoplasia; other localized
malignancies require agreement between the investigator and the
Studymedical monitor for inclusion of the subject prior to randomization;
14. Subjects who in the investigator's judgment pose a significant
suicidality risk. Subject's history of suicidal behavior and/or suicidal
ideation should be considered when evaluating for suicide risk;
15. Any pre-existing physical or mental condition (including substance
abuse disorder) which, in the opinion of the Investigator, may interfere
with the subject's ability to comply with the dosing schedule and/or
protocol evaluations or which may compromise the safety of the subject;
16. Any condition which, in the opinion of the Investigator, may interfere
with the absorption, distribution, metabolism or excretion of the study
drugs or render the subject unable to take oral medication;
Exclusionary Treatments prior to Screening or Day 1
17. Use of medications which are associated with Torsades de Pointes.
(See SPM for a list of relevant medications);
18. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days
of Screening;
19. Treatment with any of the following agents within 28 days of
Screening: radiation therapy; cytotoxic chemotherapeutic agents; any
immunomodulators that alter immune responses (a list of examples is
provided in the SPM);
20. Exposure to an experimental drug or experimental vaccine within
either 28 days, 5 half-lives of the test agent, or twice the duration of the
biological effect of the test agent, whichever is longer, prior to the first
dose of investigational product (IP);
**Please refer to study Protocol 201636, for continuing list of the
Exclusion Criteria** |
Criterios excluyentes previos a la Selección o Día 1
1. Cualquier determinación del ARN del VIH-1 en plasma ≥ 50 c/ml en
los 6 meses previos a la Selección y después de supresión confirmada a
< 50 c/ml con el TAR actual.
2. Cualquier determinación del ARN del VIH-1 en plasma > 200 c/ml en
la ventana de 6 a 12 meses anterior a la Selección y después de
supresión confirmada a < 50 c/ml.
3. Dos o más determinaciones del ARN del VIH-1 en plasma ≥ 50 c/ml en
la ventana de 6 a 12 meses anterior a la Selección y después de
supresión confirmada a < 50 c/ml.
4. Cualquier descanso farmacológico durante la ventana entre el inicio
del primer TAR del VIH y 6 meses antes de la Selección, excepto durante
periodos breves (menos de 1 mes) en los que todos los TAR se
suspendieron por problemas de tolerabilidad y/o seguridad.
5. Cualquier cambio a un tratamiento de segunda línea, definido como la
modificación de un único fármaco o varios fármacos de manera
simultánea, debido al fracaso virológico al tratamiento (que se define
como una determinación del ARN del VIH-1 en plasma confirmada 400
c/ml tras la supresión inicial a < 50 c/ml durante el tratamiento de
primera línea del VIH).
Criterios médicos excluyentes
6. Mujeres embarazadas, en periodo de lactancia o que planean quedarse
embarazadas durante el estudio.
7. Evidencia de una enfermedad de categoría C activa según los Centers
for Disease Control and Prevention (CDC). Las excepciones son el
sarcoma de Kaposi cutáneo que no requiera tratamiento sistémico y un
recuento de linfocitos CD4+ < 200 células/mm3 en el pasado.
8. Sujetos con insuficiencia hepática grave (Categoría C) según lo
determinado por la clasificación de Child-Pugh (Apéndice 2).
9. Hepatopatía inestable (según se define por la presencia de cualquiera
de las siguientes afecciones: ascitis, encefalopatía, coagulopatía,
hipoalbuminemia, varices esofágicas o gástricas o ictericia persistente)
cirrosis, anomalías biliares conocidas (con la excepción del síndrome de
Gilbert o cálculos biliares asintomáticos).
10. Evidence of Hepatitis B virus (HBV) infection based on the results of
testing for Hepatitis B surface antigen (HBsAg), Hepatitis B core
antibody (anti-HBc), and antibodies against Hepatitis B surface antigen
(anti-HBsAg) as follows:
- Subjects positive for HBsAg are excluded;
- Subjects positive for anti-HBc (negative HBsAg status) and negative for
anti-HBsAg are excluded.
11. Subjects with an anticipated need for any Hepatitis C virus (HCV)
therapy during the Early Switch Phase and for interferon-based therapy
for HCV throughout the entire study period;
A subject will not be eligible for inclusion in this study if any of the
following criteria apply:
12. History or presence of allergy to the study drugs or their components
or drugs of their class;
13. Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal
cell carcinoma, or resected, non-invasive cutaneous squamous cell
carcinoma, or cervical intraepithelial neoplasia; other localized
malignancies require agreement between the investigator and the
Studymedical monitor for inclusion of the subject prior to randomization;
14. Subjects who in the investigator's judgment pose a significant
suicidality risk. Subject's history of suicidal behavior and/or suicidal
ideation should be considered when evaluating for suicide risk;
15. Any pre-existing physical or mental condition (including substance
abuse disorder) which, in the opinion of the Investigator, may interfere
with the subject's ability to comply with the dosing schedule and/or
protocol evaluations or which may compromise the safety of the subject;
16. Any condition which, in the opinion of the Investigator, may interfere
with the absorption, distribution, metabolism or excretion of the study
drugs or render the subject unable to take oral medication;
Exclusionary Treatments prior to Screening or Day 1
17. Use of medications which are associated with Torsades de Pointes.
(See SPM for a list of relevant medications);
18. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days
of Screening;
19. Treatment with any of the following agents within 28 days of
Screening: radiation therapy; cytotoxic chemotherapeutic agents; any
immunomodulators that alter immune responses (a list of examples is
provided in the SPM);
20. Exposure to an experimental drug or experimental vaccine within
either 28 days, 5 half-lives of the test agent, or twice the duration of the
biological effect of the test agent, whichever is longer, prior to the first
dose of investigational product (IP);
**Please refer to study Protocol 201636, for continuing list of the
Exclusion Criteria** |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of subjects with plasma HIV-1 RNA <50 copies per milliliter
(c/mL) at Week 48 using the Snapshot algorithm for the Intent-to-treat
exposed (ITT-E) population. |
Porcentaje de sujetos con ARN del VIH-1 en plasma < 50 copias por
mililitro (c/ml) en la Semana 48 utilizando el algoritmo Snapshot para la
población por intención de tratar expuesta (ITT-E). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Change from Baseline in CD4+ lymphocyte count at Weeks 24 and 48;
Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 24, using the Snapshot algorithm for the ITT-E Population;
Incidence and severity of adverse events (AEs) and laboratory
abnormalities over 48 weeks;
Proportion of subjects who discontinue treatment due to AEs over 48
weeks;
Change from Baseline in renal, bone, and cardiovascular biomarkers at
Week 48;
Change from Baseline in fasting lipids at Weeks 24 and 48;
Incidence of observed genotypic and resistance to CAR and to DTG or
RPV for subjects meeting Virologic Withdrawal Criteria;
Pre-dose concentrations of DTG and RPV at Weeks 4, 24, 48, 56, 76, 100,
or Withdrawal in subjects switching to DTG + RPV
Pre-dose concentrations of DTG and RPV at Weeks 2, 4 and 8 in the first
20 subjects in the NNRTI Subset who switch from EFV or NVP to DTG
+RPV
By Baseline third agent treatment class:
Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 48
using the Snapshot algorithm for the ITT-E Population;
Changes from Baseline in CD4+ lymphocyte counts at Week 48;
Incidence and severity of AEs and laboratory abnormalities over 48
weeks;
Proportion of subjects who discontinue treatment due to AEs over 48
weeks;
Incidence of observed genotypic and phenotypic resistance to current
antiretroviral regimen and to DTG or RPV for subjects meeting Virologic
Withdrawal Criteria;
Change from Baseline in fasting lipids at Weeks 24 and 48;
Between and within treatment group comparisons will be assessed on
change from Baseline in pre-specified treatment symptoms (using the
HIV Symptom Index) at Weeks 4, 24, 48, 56, 76, 100 and 148 (or
Withdrawal from the study);
Between and within treatment group comparisons will be assessed on
change from Baseline treatment satisfaction (using the HIV TSQ) at
Weeks 4, 24, 48, 56, 76, 100 and 148 (or Withdrawal from the study) |
- Cambio frente al valor basal en el recuento linfocitario de CD4+ en las
Semanas 24 y 48
- Porcentaje de sujetos con ARN del VIH-1 en plasma < 50 c/ml en la
Semana 24, utilizando el algoritmo Snapshot para la población ITT-E
- Incidencia y gravedad de los acontecimientos adversos (AA) y
anomalías de laboratorio durante 48 semanas
- Porcentaje de sujetos que interrumpen el tratamiento por la aparición
de AA durante 48 semanas
- Cambio frente al valor basal en los biomarcadores renales, óseos y
cardiovasculares en la Semana 48
- Cambio frente al valor basal de los valores de lípidos en ayunas en las
Semanas 24 y 48
- Incidencia observada de resistencia genotípica y fenotípica a TARA y a
DTG o RPV en sujetos que cumplan los criterios de Retirada por
Confirmación Virológica
- Concentraciones predosis de DTG y RPV en las Semanas 4, 24, 48, 56,
76, 100 o Retirada en sujetos que cambian a DTG + RPV
- Concentraciones predosis de DTG y RPV en las Semanas 2, 4 y 8 en los
primeros 20 sujetos del subgrupo con ITINN que cambian de EFV o NVP
a DTG + RPV
- En función de la clase de tratamiento con un tercer agente al inicio:
- Porcentaje de sujetos con ARN del VIH-1 en plasma < 50 c/ml en la
Semana 48, utilizando el algoritmo Snapshot para la población ITT-E
- Cambios frente al valor basal en el recuento linfocitario de CD4+ en la
Semana 48
- Incidencia y gravedad de los AA y anomalías de laboratorio durante 48
semanas
- Porcentaje de sujetos que interrumpen el tratamiento por la aparición
de AA durante 48 semanas
- Incidencia observada de resistencia genotípica y fenotípica al
tratamiento antirretroviral actual y a DTG o RPV en sujetos que cumplan
el criterio de Retirada por Confirmación Virológica
- Cambio frente al valor basal de los valores de lípidos en ayunas en las
Semanas 24 y 48
- Se evaluarán las comparaciones entre grupos terapéuticos y dentro del
propio grupo con respecto al cambio frente al valor basal de los síntomas
del tratamiento previamente especificado (utilizando el Cuestionario
sobre las molestias de los Síntomas) en las Semanas 4, 24, 48, 56, 76,
100 y 148 (o Retirada del estudio)
- Se evaluarán las comparaciones ente grupos terapéuticos y dentro del
propio grupo con respecto al cambio frente al valor basal de la
satisfacción con el tratamiento (utilizando el HIVTSQ) en las Semanas 4,
24, 48, 56, 76, 100 y 148 (o Retirada del estudio) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please see field E.5.2 above for timepoints |
Ver Sección E.5.2 para los tiempos de evaluación. |
|
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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
current antiretroviral regimen (CAR) |
|
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 43 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Canada |
France |
Germany |
Italy |
Netherlands |
Russian Federation |
Spain |
Taiwan |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
The end of the study is defined as the last subject's last visit/Contact. |
Última visita/contacto del último paciente. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
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 | 3 |
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 |