Ignite Creation Date:
2025-12-24 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT01148004
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2010-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2013-07-29
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
\- Patients infected with the human immunodeficiency virus (HIV) are often treated with protease inhibitors that help fight HIV infection. However, these medications often increase blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can lead to heart disease and other problems. Patients may take drugs known as fibrates (such as gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses patients often cannot reach goal triglyceride levels. Research suggests that fibrates and certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease the effectiveness of the fibrate treatment. More research is needed to determine the best drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor therapy.
Objectives:
\- To evaluate the drug-drug interaction between fenofibrate and protease inhibitors lopinavir/ritonavir and ritonavir.
Eligibility:
\- Healthy individuals between 18 and 60 years of age.
Design:
* This study will require a screening visit and 18 study visits. The screening visit will take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the study, not including the screening visit, is 48 days. Three of the visits will take about 12 hours, and the remaining 15 visits will take about 1 hour.
* For study days 1 to 7, participants will take fenofibrate alone. Participants will keep a daily record of medication doses and any side effects.
* For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants will keep a daily record of medication doses and any side effects.
* For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir. Participants will keep a daily record of medication doses and any side effects.
* Participants will have regular study visits to provide blood samples for research and monitoring.
\- Patients infected with the human immunodeficiency virus (HIV) are often treated with protease inhibitors that help fight HIV infection. However, these medications often increase blood cholesterol levels, particularly triglycerides and low-density lipoproteins, and can lead to heart disease and other problems. Patients may take drugs known as fibrates (such as gemfibrozil (Lopid )) to lower triglyceride levels, but even with maximum approved doses patients often cannot reach goal triglyceride levels. Research suggests that fibrates and certain HIV medications, such as ritonavir and lopinavir/ritonavir, may interact and decrease the effectiveness of the fibrate treatment. More research is needed to determine the best drug to lower triglyceride levels in HIV patients who are receiving protease inhibitor therapy.
Objectives:
\- To evaluate the drug-drug interaction between fenofibrate and protease inhibitors lopinavir/ritonavir and ritonavir.
Eligibility:
\- Healthy individuals between 18 and 60 years of age.
Design:
* This study will require a screening visit and 18 study visits. The screening visit will take 3 to 4 hours, and can occur 7 to 30 days before starting the study. The rest of the study, not including the screening visit, is 48 days. Three of the visits will take about 12 hours, and the remaining 15 visits will take about 1 hour.
* For study days 1 to 7, participants will take fenofibrate alone. Participants will keep a daily record of medication doses and any side effects.
* For study days 8 to 27, participants will take fenofibrate and ritonavir. Participants will keep a daily record of medication doses and any side effects.
* For study days 29 to 48, participants will take fenofibrate and lopinavir/ritonavir. Participants will keep a daily record of medication doses and any side effects.
* Participants will have regular study visits to provide blood samples for research and monitoring.
Detailed Description:
Highly active antiretroviral therapy (HAART) has enhanced the life expectancy of human immunodeficiency virus (HIV) infected patients, making HIV a manageable chronic disease for many patients. Patients with HIV are prone to lipid abnormalities secondary to HIV infection and antiretroviral therapy, particularly HIV protease inhibitors (PI). PI containing regimens that contain boosting doses of ritonavir (RTV) (i.e., 100 200 mg once or twice daily) often cause significant increases in total cholesterol, low density lipoprotein cholesterol, and triglycerides. Therapy for isolated hypertriglyceridemia includes fibric acid derivatives, such as gemfibrozil (GFZ) or fenofibrate; however, despite treatment with these agents, triglyceride levels often remain elevated in HIV infected patients treated with HAART. Many factors likely contribute to the incomplete effectiveness of fibrates in these patients. One possible contributing factor may be a clinically significant interaction between HAART and fibrates. We recently reported a mean 41 percent decrease in GFZ area under the curve when administered with the PI combination lopinavir/ritonavir (LPV/r). To determine whether a similar interaction exists with fenofibrate, this study will characterize the impact of RTV and LPV/r on the pharmacokinetic (PK) profile of fenofibrate (Tricor formulation), after a single 145 mg oral dose, administered to healthy volunteers. In a single sequence study design, 13 subjects will receive a single 145 mg dose of fenofibrate on three occasions: before and after 14 days of RTV 100 mg twice daily, and after 14 days of LPV/r 400/100 mg twice daily. With the exclusion of the screening period, the total duration of the study will be 48 days. Fenofibric acid (FFA) PK will be determined for all 3 sampling periods and compared. Results from this study will inform us about a potentially clinically relevant drug drug interaction between fenofibrate and RTV boosted PI combinations. This information may therefore assist clinicians in choosing triglyceride lowering therapy for their HIV infected patients.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 10-CC-0124 | None | None | View |