Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir
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ClinicalTrials.gov Identifier: NCT01046890 |
Recruitment Status
:
Completed
First Posted
: January 12, 2010
Last Update Posted
: May 5, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Drug: Echinacea | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Drug Interactions Between Echinacea Purpurea and Darunavir/Ritonavir |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | April 2010 |
Arm | Intervention/treatment |
---|---|
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
|
- plasma concentration of darunavir and ritonavir [ Time Frame: DAY 14 ]
- Clearance (CL/F) [ Time Frame: DAY 14 ]
- Volume of distribution (V/F) [ Time Frame: DAY 14 ]
- Elimination half-life (t1/2) [ Time Frame: DAY 14 ]
- Area under the plasma concentration-time curve during the dosing interval [ Time Frame: DAY 14 ]
- Adverse events and laboratory alterations [ Time Frame: DAY 14 ]
- HIV Viral load in plasma [ Time Frame: DAY 14 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046890
Spain | |
Lluita contra la Sida Foundation, HIV Unit, Irsi Caixa Foundation | |
Badalona, Spain, 08916 |
Principal Investigator: | Jose Moltó, MD,PhD | Lluita contra la Sida Foundation, HIV Unit |
Responsible Party: | Lluita Sida Foundation |
ClinicalTrials.gov Identifier: | NCT01046890 History of Changes |
Other Study ID Numbers: |
EQUIDAR |
First Posted: | January 12, 2010 Key Record Dates |
Last Update Posted: | May 5, 2010 |
Last Verified: | May 2010 |
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 |