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

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ClinicalTrials.gov Identifier: NCT00460746
Recruitment Status : Completed
First Posted : April 16, 2007
Results First Posted : November 10, 2009
Last Update Posted : July 31, 2013
Sponsor:
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV
Intervention: Drug: TMC125, Darunavir; Ritonavir

  Participant Flow

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

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) 
Overall Participants Analyzed 
[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

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 ]
  Show Outcome Measure 1

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 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title 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.
Measure Description No text entered.
Time Frame 48 weeks  

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) 
Participants Analyzed 
[Units: Participants]
 		 10 
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. 
[Units: Percentage of participants]
 		 
Baseline (Day 1)   100 
Week 2   90 
Week 4   90 
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 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.



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 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information