Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
Klíčová slova
Abstraktní
Popis
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.
Termíny
| Poslední ověření: | 11/30/2019 |
| První předloženo: | 01/10/2010 |
| Odhadovaná registrace vložena: | 01/10/2010 |
| První zveřejnění: | 01/11/2010 |
| Poslední aktualizace byla odeslána: | 12/02/2019 |
| Poslední aktualizace zveřejněna: | 12/03/2019 |
| Aktuální datum zahájení studie: | 12/31/2009 |
| Odhadované datum dokončení primární: | 02/28/2010 |
| Odhadované datum dokončení studie: | 03/31/2010 |
Stav nebo nemoc
Intervence / léčba
Drug: darunavir/ritonavir + root of Echinacea purpurea
Fáze
Skupiny zbraní
| Paže | Intervence / léčba |
|---|---|
| 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 |
Kritéria způsobilosti
| Věky způsobilé ke studiu | 18 Years Na 18 Years |
| Pohlaví způsobilá ke studiu | All |
| Přijímá zdravé dobrovolníky | Ano |
| Kritéria | 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 |
Výsledek
Primární výsledná opatření
1. plasma concentration of darunavir and ritonavir [DAY 14]
Měření sekundárních výsledků
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]
