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| Name | Class |
|---|---|
| IrsiCaixa | OTHER |
| Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| darunavir/ritonavir + root of Echinacea purpurea | Experimental | darunavir/ritonavir + root of Echinacea purpurea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinacea | Drug | darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentration of darunavir and ritonavir | DAY 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Clearance (CL/F) | DAY 14 | |
| Volume of distribution (V/F) | DAY 14 | |
| Elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Moltó, MD,PhD | Lluita contra la Sida Foundation, HIV Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation | Badalona | 08916 | Spain |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| C000718679 | Echinacea extract |
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| DAY 14 |
| Area under the plasma concentration-time curve during the dosing interval | DAY 14 |
| Adverse events and laboratory alterations | DAY 14 |
| HIV Viral load in plasma | DAY 14 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |