Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.

This study has been completed.
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc
ClinicalTrials.gov Identifier:
NCT00460746
First received: April 13, 2007
Last updated: July 24, 2013
Last verified: July 2013
Results First Received: October 2, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: TMC125, Darunavir; Ritonavir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Darunavir(TMC114)/Eravirine(TMC125) Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.

Participant Flow:   Overall Study
    Darunavir(TMC114)/Eravirine(TMC125)  
STARTED     10  
COMPLETED     8  
NOT COMPLETED     2  
Adverse Event                 1  
Lost to Follow-up                 1  



  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
Darunavir(TMC114)/Eravirine(TMC125) Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.

Baseline Measures
    Darunavir(TMC114)/Eravirine(TMC125)  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Median ( Full Range )
  48  
  ( 35 to 61 )  
Gender  
[units: participants]
 
Female     0  
Male     10  
Race/Ethnicity, Customized  
[units: participants]
 
White     6  
Hispanic     4  
Viral Load <50 copies/mL  
[units: participants]
  10  
CD4 count  
[units: cells/mm^3]
Median ( Full Range )
  301  
  ( 187 to 663 )  



  Outcome Measures
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1.  Primary:   Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.   [ Time Frame: 48 weeks ]
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Measure Type Primary
Measure Title Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.
Measure Description No text entered.
Time Frame 48 weeks  
Safety Issue No  

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.
ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36.

Reporting Groups
  Description
Darunavir(TMC114)/Eravirine(TMC125) Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.

Measured Values
    Darunavir(TMC114)/Eravirine(TMC125)  
Number of Participants Analyzed  
[units: participants]
  10  
Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.  
[units: percentage¬†of¬†participants]
 
Baseline (Day 1)     100  
Week 2     100  
Week 4     100  
Week 8     90  
Week 12     80  
Week 16     90  
Week 24     90  
Week 36     90  
Week 48     80  
Post-Treatment Follow Up     90  

No statistical analysis provided for Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.



2.  Secondary:   Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.   [ Time Frame: 48 weeks ]

3.  Secondary:   CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks.   [ Time Frame: Week 48 ]

4.  Secondary:   CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks.   [ Time Frame: Week 48 ]

5.  Secondary:   Median Change From Baseline in Triglycerides at Week 48.   [ Time Frame: Week 48 ]

6.  Secondary:   Median Change From Baseline in Total Cholesterol at Week 48.   [ Time Frame: Week 48 ]

7.  Secondary:   Median Change From Baseline in LDL Cholesterol at Week 48.   [ Time Frame: Week 48 ]

8.  Secondary:   Median Change From Baseline in HDL Cholesterol.   [ Time Frame: Week 48 ]

9.  Secondary:   Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48.   [ Time Frame: Week 48 ]

10.  Secondary:   Median Change From Baseline in Glucose at Week 48.   [ Time Frame: Week 48 ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
Conclusions on efficacy and safety are limited as the target enrollment of 40 subjects was not reached due to a shortage of eligible subjects.  


Results Point of Contact:  
Name/Title: Vice President, Tibotec Therapeutics Clinical Affairs
Organization: Tibotec Therapeutics Clinical Affairs, Division of Centocor Ortho Biotech Services, LLC
phone: 877-732-2488
e-mail: rfalcon@its.jnj.com


No publications provided


Responsible Party: Tibotec, Inc
ClinicalTrials.gov Identifier: NCT00460746     History of Changes
Other Study ID Numbers: CR011866, TMC114HIV3009
Study First Received: April 13, 2007
Results First Received: October 2, 2009
Last Updated: July 24, 2013
Health Authority: United States: Food and Drug Administration