Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Mots clés
Abstrait
La description
15 patients on antiretroviral therapy with darunavir/ritonavir 600/100 mg twice a day during four weeks will be recruited. The patients will receive treatment with Echinacea purpurea for 14 days, 500 mg every 6 hours. A 12 hour pharmacokinetic curve will be obtained at baseline and on day 14.
Rendez-vous
| Dernière vérification: | 11/30/2019 |
| Première soumission: | 01/10/2010 |
| Inscription estimée soumise: | 01/10/2010 |
| Première publication: | 01/11/2010 |
| Dernière mise à jour soumise: | 12/02/2019 |
| Dernière mise à jour publiée: | 12/03/2019 |
| Date de début réelle de l'étude: | 12/31/2009 |
| Date d'achèvement primaire estimée: | 02/28/2010 |
| Date estimée d'achèvement de l'étude: | 03/31/2010 |
Condition ou maladie
Intervention / traitement
Drug: darunavir/ritonavir + root of Echinacea purpurea
Phase
Groupes d'armes
| Bras | Intervention / traitement |
|---|---|
| Experimental: darunavir/ritonavir + root of Echinacea purpurea darunavir/ritonavir + root of Echinacea purpurea | Drug: darunavir/ritonavir + root of Echinacea purpurea darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours |
Critère d'éligibilité
| Âges éligibles aux études | 18 Years À 18 Years |
| Sexes éligibles à l'étude | All |
| Accepte les bénévoles en santé | Oui |
| Critères | Inclusion Criteria: 1. Patients infected with HIV-1 (at least one documented positive Western-Blot). 2. Age =/+ 18 years. 3. Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks 4. HIV viral load in plasma <50 copies / mL 5. Absence of acute infections and / or tumors in the three months prior to inclusion. 6. Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments. 7. Voluntary written informed consent. Exclusion Criteria: 1. Any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction. 2. Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis). 3. Pregnancy or lactation |
Résultat
Mesures des résultats primaires
1. plasma concentration of darunavir and ritonavir [DAY 14]
Mesures des résultats secondaires
1. Clearance (CL/F) [DAY 14]
2. Volume of distribution (V/F) [DAY 14]
3. Elimination half-life (t1/2) [DAY 14]
4. Area under the plasma concentration-time curve during the dosing interval [DAY 14]
5. Adverse events and laboratory alterations [DAY 14]
6. HIV Viral load in plasma [DAY 14]
