NCT01148004

The Influence of Ritonavir, Alone and in Combination With Lopinavir, on Fenofibric Acid Pharmacokinetics in Healthy Volunteers

Completed Phase 1 Last updated 9 December 2019

What this trial tests

Phase 1 trial testing Fenofibrate in HIV in 25 participants. Completed in 29 July 2013.

Timeline

13 May 2010

Primary endpoint
29 July 2013

29 July 2013

Quick facts

Lead sponsor	National Institutes of Health Clinical Center (CC)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	25
Start date	13 May 2010
Primary completion	29 July 2013
Estimated completion	29 July 2013
Sites	1 location across United States

Drugs / interventions tested

• Fenofibrate (FENOFIBRATE) — full drug profile →
• Ritonavir (ritonavir) — full drug profile →
• Lopinavir/Ritonavir

Conditions studied

• HIV — all drugs for HIV →
• Fenofibrate — all drugs for Fenofibrate →
• Protease Inhibitors — all drugs for Protease Inhibitors →
• Hypertriglyceridemia — all drugs for Hypertriglyceridemia →

Sponsor

National Institutes of Health Clinical Center (CC)

Who can join

Adults 18 to 60, any sex, with HIV or Fenofibrate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.