Descrizione riassuntiva della sperimentazione (Fonte di dati: BASEC)
Cette étude a pour but 1) d’évaluer l’efficacité du dolutégravir + emtricitabine 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 + emtricitabine en bi-thérapie. 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 simplifié et décentralisé.
La durée de l'étude est de 48 semaines.
Malattie studiate(Fonte di dati: BASEC)
Infection par virus de l’immunodéficience humaine (VIH)
Health conditions
(Fonte di dati: WHO)
HIV-1-infection;Antiretroviral Therapy;Maintenance Therapy
Malattia rara
(Fonte di dati: BASEC)
No
Interventi esaminati (p. es. medicamento, terapia, campagna)
(Fonte di dati: BASEC)
Traitement simplifié: dolutégravir 50mg + emtricitabine 200 mg une fois par jour en traitement combiné 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
(Fonte di dati: WHO)
Drug: Switch to DTG + FTC;Other: Patient-centered monitoring
Criteri per la partecipazione alla sperimentazione
(Fonte di dati: 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.
Criteri di esclusione
(Fonte di dati: BASEC)
- Antécédent d'échec ou de mauvaise réponse virologique sous traitement antirétroviral. Les changements de traitement antirétroviral pour intolérance, toxicité, simplification sont permis
Inclusion/Exclusion Criteria
(Fonte di dati: 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, i.e.:
- 2 NRTIs + either 1 NNRTI, 1 boosted PI or 1 INSTI;
- NRTI-sparing triple ARV regimen (e.g. 1 NRTI + 1 NNRTI + 1 InSTI);
- Dual therapy with protease inhibitor.
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.
Note: patients with documented genotype(s) presenting only a M184V mutation remain
eligible;
3. Creatinine clearance < 50ml/min;
4. ASAT or ALAT >2.5x upper limit of the norm;
5. Known hypersensitivity, intolerance or allergy to DTG or FTC;
6. Known or suspected non-adherence (defined as <80% adherence, i.e. missed doses >
1x/week) to current treatment in the last 6 months;
7. Concomitant use of drugs that decrease DTG blood concentrations including
carbamazepine, oxcarbamazepine, phenytoin, phenobarbital, St John's wort and
rifampicin;
8. Women who are pregnant or breast-feeding;
9. a. Presence of any INSTI-resistance. Non-availability of INSTI resistance testing is
NOT an exclusion criteria.
b. Non availability of previous routine resistance test, at least for reverse
transcriptase and protease genes.
Note: Subjects remain eligible in the absence of any previous resistance test only if
they are on their first-line antiretroviral regimen;
10. Evidence of acute or chronic hepatitis B virus infection based on results of serology
testing.
-
Altre informazioni sulla sperimentazione
Data di registrazione della sperimentazione
16 mag 2017
Inserimento del primo partecipante
19 mag 2017
Stato di reclutamento
Completed
Titolo scientifico
(Fonte di dati: WHO)
Evaluation of a Simplified Strategy for the Long-term Management of HIV Infection: a Non-inferiority, Randomized, Controlled, Open-label Clinical Trial
Tipo di sperimentazione
(Fonte di dati: WHO)
Interventional
Disegno della sperimentazione
(Fonte di dati: WHO)
Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Fase
(Fonte di dati: WHO)
Phase 4
Punti finali primari
(Fonte di dati: WHO)
Costs of a patient-centered ART monitoring;Efficacy of DTG-based maintenance therapy (< 100 copies/ml)
Punti finali secondari
(Fonte di dati: WHO)
Number of study-related extra clinical visits;Adherence questions;Change in patient weight;Cost-effectiveness of study arms;Study satisfaction;ARV treatment in the post study;Patient's treatment satisfaction at week 48;Proportion of patients in the patient-centered monitoring arm expressing willingness to change monitoring options;Global satisfaction of the monitoring;Patient's monitoring satisfaction for pts in the patient-centered monitoring arm;PROQOL questionnaire;Proportion of patients new to DTG with CNS symptoms;Proportion of patients with CNS adverse event;Proportion of patients with a severe adverse event;Proportion of patients with an adverse event;Change in glomerular function rate;Change in Framingham-calculated cardiovascular risk;Change in glucose profile;Change in lipidic profile;Change in HIV-DNA;Change in CD4 cell count;HIV-RNA >100 copies/ml as time to loss of virological response (TLOVR);Efficacy of DTG-based therapy (<50 copies/ml) by FDA snapshot analysis;Efficacy of DTG-based maintenance therapy (<50 copies/ml)
Contatto per informazioni
(Fonte di dati: WHO)
Please refer to primary and secondary sponsors
Risultati della sperimentazione
(Fonte di dati: WHO)
Sintesi dei risultati
ancora nessuna informazione disponibile
Collegamento ai risultati nel registro primario
ancora nessuna informazione disponibile
Informazioni sulla disponibilità dei dati dei singoli partecipanti
No
Siti di esecuzione della sperimentazione
Siti di esecuzione in Svizzera
(Fonte di dati: BASEC)
Basilea, Berna, Ginevra, Losanna, Lugano, San Gallo, Zurigo
Paesi di esecuzione
(Fonte di dati: WHO)
Switzerland
Contatto per maggiori informazioni sulla sperimentazione
Dati della persona di contatto in Svizzera
(Fonte di dati: BASEC)
Dr Marta Buzzi
+41223723351
marta.buzzi@hcuge.ch
Autorizzazione da parte della commissione d’etica (Fonte di dati: BASEC)
Nome della commissione d’etica che rilascia l’autorizzazione (nel caso di studi multicentrici solo la commissione direttiva)
Commission Cantonale
d’éthique de la recherche Genève (CCER)
Data di autorizzazione da parte della commissione d’etica
04.04.2017
Altri numeri di identificazione delle sperimentazioni
Numero di identificazione della sperimentazione della commissione d’etica (BASEC-ID)
(Fonte di dati: BASEC)
2016-02210
Secondary ID (Fonte di dati: WHO)
CCER 2016-02210
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