HIV
Conditions
Keywords
etravirine, Echinacea purpurea, interaction
Brief summary
The purpose of this clinical trial is to characterize drug interactions between one medicinal herb: Echinacea purpurea and the protease inhibitor etravirine.
Detailed description
Because of its CYP3A4 inducer activity in the liver but its inhibitor effect at the intestinal site, concomitant administration of Equinacea purpurea (a medicinal herb frequently used by HIV-infected patients) and etravirine (an HIV reverse transcriptase inhibitor) might result in clinically relevant pharmacokinetic drug interactions. 15 HIV-infected patients on stable antiretroviral therapy including etravirine at the dosage of 200 mg twice daily during at least 4 weeks will be enrolled. After their inclusion in the study, patients will receive Echinacea purpurea root (500 mg every 8 hours) in addition to their antiretroviral treatment, from day 1 until two weeks later (day 14). On days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of an etravirine dose, and etravirine concentrations in plasma will be determined by high performance liquid chromatography using a validated method.
Interventions
DIETARY_SUPPLEMENTEchinacea purpurea
Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
Sponsors
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Patients infected with HIV-1 (at least one documented positive Western-Blot). 2. Age 18 years or more. 3. Patients receiving antiretroviral therapy including etravirine at the approved dose of 200 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. Antiretroviral regimen including drugs ritonavir or atazanavir (CYP3A4 inhibitors) 3. Concomitant treatment with drugs inductors of CYP3A4 (rifampicin, fenitoin, carbamazepin, ...) 4. Active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis). 5. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma concentration of etravirine. | Change from baseline to day 14 | plasma concentration of etravirine. |
Secondary
| Measure | Time frame |
|---|---|
| Volume of distribution (V/F) | Change from baseline to day 14 |
| Elimination half-life (t1/2) | Change from baseline to day 14 |
| Area under the plasma concentration-time curve during the dosing interval (AUC0-24) | Change from baseline to day 14 |
| Clearance (CL/F) | Change from baseline to day 14 |
| HIV Viral load in plasma | Day 14 |
| Number of patients with laboratory alterations | From baseline to day 28 |
| Number of patients with adverse events | From baseline to day 28 |
Countries
Spain
Outcome results
None listed