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Drug Interaction Study of Lopinavir/Ritonavir and Gemfibrozil (GEM-PK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00474201
First Posted: May 16, 2007
Last Update Posted: September 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Scott Penzak, Pharm.D., National Institutes of Health Clinical Center (CC)
Results First Submitted: March 23, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition: Healthy Volunteers
Interventions: Drug: Lopinavir/Ritonavir
Drug: Gemfibrozil

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Up to 30 healthy volunteers will be screened to enroll a total of 15 healthy volunteers. We will actively encourage participation of all ethnic groups and females. Recruitment of HIV-negative volunteers will be done through the normal volunteer office at NIH.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who meet inclusion criteria and do not meet any exclusion criteria will be invited to participate in the study.

Reporting Groups
  Description
Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.

Participant Flow:   Overall Study
    Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.

Baseline Measures
   Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 37  (10) 
Gender 
[Units: Participants]
 
Female   7 
Male   8 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   Gemfibrozil Area Under the Concentration vs. Time Curve (AUC)   [ Time Frame: 22 days per subject (approximately 1 year for entire study completion) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott Penzak
Organization: National Institutes of Health
phone: 301-496-2997
e-mail: sp286u@nih.gov


Publications of Results:

Responsible Party: Scott Penzak, Pharm.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00474201     History of Changes
Other Study ID Numbers: 070149
07-CC-0149 CL006000-01 CC ( Other Identifier: Clinical Center Z number )
First Submitted: May 15, 2007
First Posted: May 16, 2007
Results First Submitted: March 23, 2010
Results First Posted: April 9, 2012
Last Update Posted: September 26, 2016