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Trial record 44 of 56 for:    " September 09, 2009":" October 09, 2009"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses. (ENCORE3)

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ClinicalTrials.gov Identifier: NCT00985543
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : March 29, 2011
Last Update Posted : March 29, 2011
Sponsor:
Information provided by:
Kirby Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acquired Immunodeficiency Syndrome
Intervention Drug: lopinavir/ritonavir
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
22
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
36  (9.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
8
  36.4%
Male
14
  63.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 22 participants
22
1.Primary Outcome
Title Plasma Lopinavir/Ritonavir Concentrations as Measured by the Area Under the Curve (AUC 0-12h).
Hide Description Pharmacokinetics of plasma lopinavir/ritonavir over a 12-hour dosing interval following administration of lopinavir/ritonavir 400/100mg, 200/150mg and 200/50mg twice daily.
Time Frame at the end of each 7-day dosing phase
Hide Outcome Measure Data
Hide Analysis Population Description
22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).
Arm/Group Title LPV/r 400/100 mg LPV/r 200/150 mg LPV/r 200/50 mg
Hide Arm/Group Description:
Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
Overall Number of Participants Analyzed 22 22 22
Geometric Mean (90% Confidence Interval)
Unit of Measure: ng.h/mL
99599
(87180 to 113787)
73603
(65121 to 83191)
45146
(39251 to 51927)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LPV/r 400/100 mg, LPV/r 200/150 mg, LPV/r 200/50 mg
Comments Dosing regimens lopinavir/ritonavir 200/150mg BID (Phase 2) and lopinavir/ritonavir 200/50mg BID (Phase 3) will be considered equivalent to lopinavir/ritonavir 400/100mg BID (Phase 1) if the 90% confidence interval (CI) for the mean AUC0–12h ratio and maximum concentration (Cmax) ratio lie between 0.80 and 1.25.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Results are considered statistically significant at p<0.05 or when 90% confidence intervals do not cross the value 1. No adjustments are made for multiple comparisons.
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method maximum likelihood regression
Comments [Not Specified]
2.Secondary Outcome
Title Adverse Events
Hide Description Number of reported adverse events, severity of adverse events and relationship to study drug was assessed by questions, physical examination and laboratory parameters. Adverse event data was used to assess the safety and tolerability of low lopinavir/ritonavir doses.
Time Frame Up to 11 weeks from screening to final study visit
Hide Outcome Measure Data
Hide Analysis Population Description
22 participants completed the three sequential dosing phases and pharmacokinetic evaluations as per protocol. The same 22 participants are in the analysis population for each lopinavir/ritonavir dose (arm).
Arm/Group Title LPV/r 400/100 mg LPV/r 200/150 mg LPV/r 200/50 mg
Hide Arm/Group Description:
Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
Overall Number of Participants Analyzed 22 22 22
Measure Type: Number
Unit of Measure: number of adverse events
27 2 4
Time Frame Up to 11 weeks from screening visit until the participant's final study visit.
Adverse Event Reporting Description Any adverse event that occurred after the reporting period that the PI assesses as possibly, probably or definitely related to the study drug was also reported.
 
Arm/Group Title All Study Participants
Hide Arm/Group Description All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
All-Cause Mortality
All Study Participants
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Study Participants
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Study Participants
Affected / at Risk (%) # Events
Total   15/22 (68.18%)    
Gastrointestinal disorders   
Diarrhoea * 1  7/22 (31.82%)  7
General disorders   
Fatigue * 1  4/22 (18.18%)  4
Headache * 1  4/22 (18.18%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PI shall not publish or otherwise disseminate the conclusions of the Study, including all or any part of the Results without the prior written consent of the Sponsor, such consent not to be unreasonably withheld or delayed. Any publication or other dissemination of the conclusions of the Study by the PI shall not occur until the Sponsor has published the conclusions of the Study.
Results Point of Contact
Name/Title: Dr Marta Boffito
Organization: St Stephens Centre, Chelsea and Westminster Hospital
Phone: +44 2088 466 507
Responsible Party: Marta Boffito, Chelsea and Westminster Hospital
ClinicalTrials.gov Identifier: NCT00985543     History of Changes
Other Study ID Numbers: NCHECR-ENCORE3
First Submitted: September 25, 2009
First Posted: September 28, 2009
Results First Submitted: February 4, 2011
Results First Posted: March 29, 2011
Last Update Posted: March 29, 2011