Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
This study has been completed.
Sponsor:
Germans Trias i Pujol Hospital
Collaborator:
IrsiCaixa
Information provided by:
Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT01046890
First received: January 11, 2010
Last updated: May 4, 2010
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: Echinacea |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir |
Resource links provided by NLM:
Further study details as provided by Germans Trias i Pujol Hospital:
Primary Outcome Measures:
- plasma concentration of darunavir and ritonavir [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clearance (CL/F) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
- Volume of distribution (V/F) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
- Elimination half-life (t1/2) [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
- Area under the plasma concentration-time curve during the dosing interval [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
- Adverse events and laboratory alterations [ Time Frame: DAY 14 ] [ Designated as safety issue: No ]
- HIV Viral load in plasma [ Time Frame: DAY 14 ] [ Designated as safety issue: Yes ]
| Enrollment: | 15 |
| Study Start Date: | January 2010 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: darunavir/ritonavir + root of Echinacea purpurea
darunavir/ritonavir + root of Echinacea purpurea
|
Drug: Echinacea
darunavir/ritonavir 600/100 mg + root of Echinacea purpurea 500 mg every 6 hours
Other Name: N/H
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients infected with HIV-1 (at least one documented positive Western-Blot).
- Age =/+ 18 years.
- Patients receiving antiretroviral therapy containing darunavir / ritonavir at the approved dose of 600/100 mg twice daily for at least 4 weeks
- HIV viral load in plasma <50 copies / mL
- Absence of acute infections and / or tumors in the three months prior to inclusion.
- Subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments.
- Voluntary written informed consent.
Exclusion Criteria:
- 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.
- Active alcohol consumption (> 50 g / day) or illicit drugs (except cannabis).
- Pregnancy or lactation
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046890
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046890
Locations
| Spain | |
| Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation | |
| Badalona, Spain, 08916 | |
Sponsors and Collaborators
Germans Trias i Pujol Hospital
IrsiCaixa
Investigators
| Principal Investigator: | Jose Moltó, MD,PhD | Lluita contra la Sida Foundation, HIV Unit |
More Information
| Responsible Party: | Lluita Sida Foundation |
| ClinicalTrials.gov Identifier: | NCT01046890 History of Changes |
| Other Study ID Numbers: | EQUIDAR |
| Study First Received: | January 11, 2010 |
| Last Updated: | May 4, 2010 |
| Health Authority: | Spain: Ministry of Health |
Keywords provided by Germans Trias i Pujol Hospital:
|
Darunavir Echinacea purpurea Interaction Complementary Therapies |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Ritonavir Darunavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 23, 2016