Trial Outcomes & Findings for Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers (NCT NCT00103012)
NCT ID: NCT00103012
Last Updated: 2012-04-16
Results Overview
The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
47 participants
Primary outcome timeframe
2 weeks
Results posted on
2012-04-16
Participant Flow
Healthy human volunteers were recruited to participate in this study throughout the course of the investigation (2005-2010).
Participant milestones
| Measure |
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
|
Influence of Echinacea on Lopinavir/Ritonavir Disposition
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
|
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
|
|---|---|---|---|
|
Overall Study
STARTED
|
17
|
14
|
16
|
|
Overall Study
COMPLETED
|
14
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
4
|
Reasons for withdrawal
| Measure |
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
|
Influence of Echinacea on Lopinavir/Ritonavir Disposition
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
|
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
2
|
|
Overall Study
Pregnancy
|
1
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
|
Overall Study
Subject non-compliant with medications
|
0
|
0
|
1
|
Baseline Characteristics
Drug Interactions of Echinacea, Ginseng, and Ginkgo Biloba Taken With Lopinavir/Ritonavir in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition
n=17 Participants
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
|
Influence of Echinacea on Lopinavir/Ritonavir Disposition
n=14 Participants
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
|
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
n=16 Participants
Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age Continuous
|
33 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
33 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
32 years
STANDARD_DEVIATION 6.4 • n=27 Participants
|
33 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
29 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
14 participants
n=4 Participants
|
16 participants
n=27 Participants
|
47 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Data was analyzed from all subjects who completed a particular sampling period.
The outcome measurement for each study arm is the change in lopinavir area under the concentration versus time curve (AUC) after two weeks administration of an herbal preparation (Ginkgo Biloba, Echinacea purpurea, or Panax Ginseng).
Outcome measures
| Measure |
Influence of Ginkgo Biloba on Lopinavir Disposition
n=14 Participants
Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
|
Influence of Echinacea on Lopinavir Disposition
n=13 Participants
Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
|
Influence of Panax Ginseng on Lopinavir Disposition
n=12 Participants
Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
|
|---|---|---|---|
|
Lopinavir Pharmacokinetics When Administered Alone and in Combination With Three Different Herbal Supplements: Ginkgo Biloba, Panax Ginsing, and Echinacea Purpurea.
|
1.02 mcg*hr/mL
Interval 0.67 to 1.38
|
0.96 mcg*hr/mL
Interval 0.83 to 1.1
|
1 mcg*hr/mL
Interval 0.3 to 2.0
|
Adverse Events
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Influence of Echinacea on Lopinavir/Ritonavir Disposition
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition
n=17 participants at risk
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
|
Influence of Echinacea on Lopinavir/Ritonavir Disposition
n=14 participants at risk
Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
|
Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition
n=16 participants at risk
Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
|
|---|---|---|---|
|
Gastrointestinal disorders
diarrhea
|
5.9%
1/17 • Number of events 2
|
78.6%
11/14 • Number of events 26
|
56.2%
9/16 • Number of events 22
|
|
Reproductive system and breast disorders
dysmenorrhea
|
5.9%
1/17 • Number of events 2
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
electrolyte imbalance
|
5.9%
1/17 • Number of events 2
|
0.00%
0/14
|
0.00%
0/16
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/17
|
35.7%
5/14 • Number of events 5
|
18.8%
3/16 • Number of events 3
|
|
Nervous system disorders
headache
|
0.00%
0/17
|
14.3%
2/14 • Number of events 2
|
43.8%
7/16 • Number of events 10
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/17
|
35.7%
5/14 • Number of events 7
|
12.5%
2/16 • Number of events 5
|
|
Infections and infestations
acute sore throat
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Eye disorders
conjunctivitis
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
sinus congestion
|
0.00%
0/17
|
7.1%
1/14 • Number of events 2
|
0.00%
0/16
|
|
Gastrointestinal disorders
flatulence
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Nervous system disorders
insomnia
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
6.2%
1/16 • Number of events 1
|
|
Nervous system disorders
decreased concentration
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
General disorders
taste alterations
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Injury, poisoning and procedural complications
anorexia
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
General disorders
cough
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Infections and infestations
fever
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
6.2%
1/16 • Number of events 2
|
|
General disorders
generalized pain
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
Gastrointestinal disorders
vomiting
|
0.00%
0/17
|
7.1%
1/14 • Number of events 1
|
0.00%
0/16
|
|
General disorders
common cold
|
5.9%
1/17 • Number of events 2
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
decreased serum albumin
|
0.00%
0/17
|
0.00%
0/14
|
18.8%
3/16 • Number of events 3
|
|
Immune system disorders
decreased absolute neutrophil count
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Hepatobiliary disorders
elevated ALT (SGPT)
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Hepatobiliary disorders
elevated AST (SGOT)
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Hepatobiliary disorders
elevated serum bilirubin
|
0.00%
0/17
|
0.00%
0/14
|
18.8%
3/16 • Number of events 3
|
|
General disorders
fatigue
|
0.00%
0/17
|
0.00%
0/14
|
12.5%
2/16 • Number of events 3
|
|
Gastrointestinal disorders
dry mouth
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 2
|
|
Metabolism and nutrition disorders
hypertriglyceridemia
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
bradycardia
|
0.00%
0/17
|
0.00%
0/14
|
12.5%
2/16 • Number of events 2
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
0.00%
0/17
|
0.00%
0/14
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
decreased hemoglobin
|
0.00%
0/17
|
0.00%
0/14
|
12.5%
2/16 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/17
|
0.00%
0/14
|
18.8%
3/16 • Number of events 3
|
Additional Information
Scott Penzak
National Institutes of Health, Clinical Center, Department of Pharmacy
Phone: 301-496-2997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place