Overview

Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Germans Trias i Pujol Hospital
Collaborators:
FundaciĆ³n FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la PromociĆ³n de la Salud y la Ciencia
IrsiCaixa
Treatments:
Darunavir
Ritonavir
Criteria
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