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NCT03160105 | SNCTP000002179

Etude de simplification de traitement par monothérapie de dolutégravir et de décentralisation du suivi de traitement chez les personnes porteuses du VIH et avirémiques sous thérapie antirétrovirale conventionnelle

Datenbasis: BASEC (Import vom 19.09.2017), WHO (Import vom 17.09.2017)
Geändert: 12.09.2017

Zusammenfassende Beschreibung der Studie (Datenquelle: BASEC)

Cette étude a pour but 1) d’évaluer l’efficacité du dolutégravir seul comme traitement à long-terme du VIH et 2) d’évaluer les coûts et l’acceptabilité d’un suivi de traitement décentralisé. Les participants seront répartis au hasard soit pour poursuivre leur traitement antirétroviral actuel, soit pour débuter le dolutégravir en mono-traitement. Les participants éligibles sont ceux qui ont déjà une charge virale indétectable depuis au moins 6 mois sous traitement conventionnel. Les participants seront ensuite répartis, toujours au hasard, soit vers un suivi de traitement standard dans leur centre habituel, soit vers un suivi simplifé et décentralisé. La durée de l'étude est de 48 semaines.

Untersuchte Krankheiten (Datenquelle: BASEC)

Infection par virus de l’immunodéficience humaine (VIH)

Health conditions (Datenquelle: WHO)

HIV-1-infection;Antiretroviral Therapy;Maintenance Therapy;HIV-1-infection;Antiretroviral Therapy;Maintenance Therapy

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

Traitement simplifié: dolutégravir 50mg une fois par jour en traitement seul pour une durée de 48 semaines, à prendre avec ou sans repas. Suivi simplifié et décentralisé: réduction de la fréquence de mesure du taux de CD4 et autres tests de laboratoires qui ne seront fait que de manière annuelle. De plus, les participants inclus dans le suivi décentralisé choisiront une ou plus des trois options suivantes : - Réalisation des prises de sang dans un laboratoire de ville situé plus près de leur maison ou de leur travail ; - Envoi des médicaments antirétroviraux à l’adresse de leur choix (maison ou travail) ; - Consultation téléphonique avec l’infirmière ou le médecin pour les visites d’étude qui ne doivent pas se faire à l’hôpital.

Interventions (Datenquelle: WHO)

Drug: Switch to DTG + FTC;Other: Patient-centered monitoring;Drug: Switch to DTG + FTC;Other: Patient-centered monitoring

Kriterien zur Teilnahme an der Studie (Datenquelle: BASEC)

- Infection VIH-1 - Charge virale < 50 copies/ml depuis au moins 24 semaines - Sous traitement antirétroviral conventionnel (selon les recommandations Européenes) au moment de l'inclusion.

Ausschlusskriterien (Datenquelle: BASEC)

- Nadir CD4 < 200 cellules/microl - Antécédent d'échec ou de mauvaise réponse virologique sous traitement antirétroviral. Les changements de traitement antirétroviral pour intolérance, toxicité, simplification sont permis - Grossesse et lactation

Inclusion/Exclusion Criteria (Datenquelle: WHO)


Inclusion Criteria:

1. Informed consent as documented by signature;

2. Documented HIV-1 infection;

3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical
doctor of the SHCS network;

4. = 18 years of age;

5. HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on
effective suppressive cART, one blip with less than 200 copies/mL being allowed
during this period if followed by at least 2 results < 50 copies/mL.

6. On standard cART at the time of inclusion (EACS guidelines).

Exclusion Criteria:

1. HIV-2 infection;

2. Previous ART change for unsatisfactory virological response, i.e. slow initial
virological suppression, incomplete suppression or rebound. Change of drug or drug
class for convenience or toxic effect prevention or management is allowed.

3. Nadir CD4 count <200 cells/µl;

4. Creatinine clearance < 50ml/min;

5. ASAT or ALAT >2.5x upper limit of the norm;

6. Known hypersensitivity or allergy to DTG or FTC;

7. Known or suspected non-adherence (defined as <80% adherence to current treatment in
the last 6 months);

8. Concomitant use of drugs that decrease DTG blood concentrations including
carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and
rifampicin;

9. Women who are pregnant or breast-feeding;

10. Intention to become pregnant during the course of the study;

11. Lack of safe contraception, defined as: female participants of childbearing
potential, not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices. Female participants who are
surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are
not considered as being of child bearing potential.

12. Documented M184V and Integrase Strand Transfer Inhibitor (INSTI)-resistance mutations
based on routine patient chart (sequence in the SmartGene database at investigator's
discretion) ;

13. Evidence of active or chronic hepatitis B virus infection based on results of
serology testing.
;
Inclusion Criteria:

1. Informed consent as documented by signature;

2. Documented HIV-1 infection;

3. Enrolled in the Swiss HIV Cohorte Study (SHCS) or receiving care from a medical
doctor of the SHCS network;

4. = 18 years of age;

5. HIV-RNA <50 copies/mL at screening and for at least 24 weeks before screening on
effective suppressive cART, one blip with less than 200 copies/mL being allowed
during this period if followed by at least 2 results < 50 copies/mL.

6. On standard cART at the time of inclusion (EACS guidelines).

Exclusion Criteria:

1. HIV-2 infection;

2. Previous ART change for unsatisfactory virological response, i.e. slow initial
virological suppression, incomplete suppression or rebound. Change of drug or drug
class for convenience or toxic effect prevention or management is allowed.

3. Nadir CD4 count <200 cells/µl;

4. Creatinine clearance < 50ml/min;

5. ASAT or ALAT >2.5x upper limit of the norm;

6. Known hypersensitivity or allergy to DTG or FTC;

7. Known or suspected non-adherence (defined as <80% adherence to current treatment in
the last 6 months);

8. Concomitant use of drugs that decrease DTG blood concentrations including
carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and
rifampicin;

9. Women who are pregnant or breast-feeding;

10. Intention to become pregnant during the course of the study;

11. Lack of safe contraception, defined as: female participants of childbearing
potential, not using and not willing to continue using a medically reliable method of
contraception for the entire study duration, such as oral, injectable, or implantable
contraceptives, or intrauterine contraceptive devices. Female participants who are
surgically sterilised/hysterectomised or post-menopausal for longer than 2 years are
not considered as being of child bearing potential.

12. Documented M184V and Integrase Strand Transfer Inhibitor (INSTI)-resistance mutations
based on routine patient chart (sequence in the SmartGene database at investigator's
discretion) ;

13. Evidence of active or chronic hepatitis B virus infection based on results of
serology testing.

Weitere Angaben zur Studie im WHO-Primärregister

https://clinicaltrials.gov/show/NCT03160105

Weitere Angaben zur Studie aus der Datenbank der WHO (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03160105

Weitere Informationen zur Studie

Registrationsdatum der Studie

16.05.2017

Einschluss der ersten teilnehmenden Person

01.05.2017

Rekrutierungsstatus

Recruiting

Wissenschaftlicher Titel (Datenquelle: WHO)

Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial

Studientyp (Datenquelle: WHO)

Interventional

Phase (Datenquelle: WHO)

Phase 4

Primäre Endpunkte (Datenquelle: WHO)

Efficacy of DTG-based maintenance therapy (< 100 copies/ml);Costs of a patient-centered ART monitoring;Efficacy of DTG-based maintenance therapy (< 100 copies/ml);Costs of a patient-centered ART monitoring

Sekundäre Endpunkte (Datenquelle: WHO)

Efficacy of DTG-based maintenance therapy (<50 copies/ml);Proportion of patients experiencing loss of future drug options;Baseline HIV-DNA as a predictors of virological failure;nadir CD4 count as a predictors of virological failure;ratio CD4/CD8 as a predictors of virological failure;peak HIV-RNA as a predictors of virological failure;age as a predictors of virological failure;years since HIV infection as a predictors of virological failure;years of HIV viral suppression as a predictors of virological failure;dolutegravir plasma concentration as a predictors of virological failure;dolutegravir pharmacogenetic variants as a predictors of virological failure;Change in CD4 cell count;Change in lipidic profile;Change in Framingham-calculated cardiovascular risk;Change in glomerular function rate;Proportion of patients with an adverse event at week 48;Proportion of patients with a severe adverse event at week 48;Proportion of patients with CNS adverse event at week 48;PROQOL questionnaire;HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR);Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options;Adherence questions;Number of study-related extra clinical visits;Efficacy of DTG-based maintenance therapy (<50 copies/ml);Proportion of patients experiencing loss of future drug options;Baseline HIV-DNA as a predictors of virological failure;nadir CD4 count as a predictors of virological failure;ratio CD4/CD8 as a predictors of virological failure;peak HIV-RNA as a predictors of virological failure;age as a predictors of virological failure;years since HIV infection as a predictors of virological failure;years of HIV viral suppression as a predictors of virological failure;dolutegravir plasma concentration as a predictors of virological failure;dolutegravir pharmacogenetic variants as a predictors of virological failure;Change in CD4 cell count;Change in lipidic profile;Change in Framingham-calculated cardiovascular risk;Change in glomerular function rate;Proportion of patients with an adverse event at week 48;Proportion of patients with a severe adverse event at week 48;Proportion of patients with CNS adverse event at week 48;PROQOL questionnaire;HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR);Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options;Adherence questions;Number of study-related extra clinical visits

Kontakt für Auskünfte (Datenquelle: WHO)

Please refer to primary and secondary sponsors;Please refer to primary and secondary sponsors

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

Basel, Bern, Genf, Lausanne, Lugano, St Gallen, Zürich

Durchführungsländer (Datenquelle: WHO)

Switzerland

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Dr Marta Buzzi
+41223723351
marta.buzzi@hcuge.ch

Kontakt für allgemeine Auskünfte (Datenquelle: WHO)

Alexandra Calmy, MD PhD;Alexandra Calmy, MD PhD
+4122 37 29 811;+4122 37 29 811
alexandra.calmy@hcuge.ch;alexandra.calmy@hcuge.ch

Kontakt für wissenschaftliche Auskünfte (Datenquelle: WHO)

Alexandra Calmy, MD PhD;Alexandra Calmy, MD PhD
+4122 37 29 811;+4122 37 29 811
alexandra.calmy@hcuge.ch;alexandra.calmy@hcuge.ch

Studienverantwortliche

Hauptsponsor (Datenquelle: WHO)

Calmy Alexandra

Weitere Studienidentifikationsnummern

BASEC ID (Datenquelle: BASEC)

2016-02210

Secondary ID (Datenquelle: WHO)

CCER 2016-02210;CCER 2016-02210