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Genetic Predictors of Variability in the Drug-drug Interaction Between Darunavir/Ritonavir and Pravastatin

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00630734
First Posted: March 7, 2008
Last Update Posted: May 22, 2014
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.
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
University of Colorado, Denver
Results First Submitted: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: HIV Infections
Hyperlipidemia
Interventions: Drug: Pravastatin
Drug: Darunavir
Drug: Ritonavir
Other: Washout

  Participant Flow


  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
SLCO1B1 Group 1 SLCO1B1 *1A/*1A diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
SLCO1B1 Group 2 SLCO1B1 *1A/*1B or *1B/*1B diplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
SLCO1B1 Group 3 Carriers of at least one SLCO1B1 *5, *15, or *17 haplotype; Pravastatin 40 mg by mouth daily on days 1-4, washout on days 5-11, darunavir/ritonavir 600/100 mg by mouth twice daily on days 12-18, with pravastatin 40 mg added back on days 15-18
Total Total of all reporting groups

Baseline Measures
   SLCO1B1 Group 1   SLCO1B1 Group 2   SLCO1B1 Group 3   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   12   7   28 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   9   12   7   28 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 36  (11)   37  (12)   39  (11)   36  (11) 
Gender 
[Units: Participants]
       
Female   2   9   4   15 
Male   7   3   3   13 
Region of Enrollment 
[Units: Participants]
       
United States   9   12   7   28 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Relative Change in Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

2.  Primary:   Relative Change in Pravastatin Maximum Plasma Concentration (Cmax)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

3.  Secondary:   Pravastatin Alone: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

4.  Secondary:   Pravastatin Alone: Pravastatin Maximum Plasma Concentration (Cmax)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

5.  Secondary:   Pravastatin + Darunavir/Ritonavir: Pravastatin Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

6.  Secondary:   Pravastatin + Darunavir/Ritonavir: Pravastatin Maximum Plasma Concentration (Cmax)   [ Time Frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24 hours post-dose ]

7.  Other Pre-specified:   Darunavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval   [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose ]

8.  Other Pre-specified:   Darunavir Maximum Plasma Concentration (Cmax)   [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose ]

9.  Other Pre-specified:   Ritonavir Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval   [ Time Frame: 0, 1, 2, 3, 4, 5, 6, 8, 12 hours post-dose ]

10.  Other Pre-specified:   Ritonavir Maximum Plasma Concentration (Cmax)   [ Time Frame: 0,1, 2, 3, 4, 5, 6, 8, 12 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study included only heterozygous carriers of the SLCO1B1 *15 and *17 haplotypes. Pravastatin urine concentrations were not measured; therefore the impact of darunavir/ritonavir on pravastatin renal clearance was not assessed in this population.


  More Information