HIV Infections
Conditions
Keywords
Darunavir, Echinacea purpurea, Interaction, Complementary Therapies
Brief summary
The purpose of this clinical trial is to characterize drug interactions between one medicinal herb widely used by HIV infected patients: Echinacea sp. and the protease inhibitor darunavir/ritonavir.
Detailed 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.
Interventions
DRUGEchinacea
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
Sponsors
IrsiCaixa
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Germans Trias i Pujol Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration of darunavir and ritonavir | DAY 14 |
Secondary
| Measure | Time frame |
|---|---|
| Volume of distribution (V/F) | DAY 14 |
| Elimination half-life (t1/2) | DAY 14 |
| Clearance (CL/F) | DAY 14 |
| Adverse events and laboratory alterations | DAY 14 |
| HIV Viral load in plasma | DAY 14 |
| Area under the plasma concentration-time curve during the dosing interval | DAY 14 |
Countries
Spain
Outcome results
None listed