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Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r (LARD)

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ClinicalTrials.gov Identifier: NCT00756730
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : July 13, 2012
Last Update Posted : August 21, 2017
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Community Research Initiative of New England

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ATV/r
Drug: DRV/r

  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
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Participant Flow:   Overall Study
    Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD
STARTED   25   24 
COMPLETED   25   22 
NOT COMPLETED   0   2 
discontinued due to rash prior to week 4                0                1 
persistent low-level viremmia                0                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
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r
Total Total of all reporting groups

Baseline Measures
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 25   24   49 
Age, Customized 
[Units: Years]
Mean (Full Range) 		 48 
 (34 to 67)  		 46 
 (30 to 60)  		 47 
 (30 to 67) 
Sex: Female, Male 
[Units: Participants]
Count of Participants 		     
Female      2   8.0%      2   8.3%      4   8.2% 
Male      23  92.0%      22  91.7%      45  91.8% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino      7  28.0%      12  50.0%      19  38.8% 
Not Hispanic or Latino      18  72.0%      11  45.8%      29  59.2% 
Unknown or Not Reported      0   0.0%      1   4.2%      1   2.0% 
Region of Enrollment 
[Units: Participants]
 		     
United States   25   24   49 
CD4 Count 
[Units: Cells/mm3]
Mean (Full Range) 		 584 
 (249 to 996)  		 554 
 (31 to 1066)  		 569 
 (31 to 1066) 
Viral Load [1] 
[Units: copies/mL]
 		 NA [1]   NA [1]   0 
[1] VL was not detected. All values were reported less than 50 copies/ml, the lower limit of detection.
Baseline antiretroviral medications - Protease inhibitors 
[Units: Participants]
 		     
Lopinavir/ritonavir (LPV/r)   23   23   46 
fosamprenavir/ritonavir (FPV/r)   2   1   3 
Baseline medications - Nucleoside analogs 
[Units: Participants]
 		     
viread (TDF)/emtriva (FTC)   15   17   32 
ziagen (ABC)/Epivir (3TC)   5   5   10 
other   5   2   7 
Lipid Lowering Medications 
[Units: Participants]
 		     
statin   6   3   9 
fibrate   5   6   11 
fish oil   5   3   8 
niacin   0   1   1 
none   9   11   20 


  Outcome Measures

1.  Primary:   Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.   [ Time Frame: baseline, 24 weeks ]

Measure Type Primary
Measure Title Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.
Measure Description A 10% decline in triglycerides (TGs) was determined to be clinically significant. The percentage of people that experienced a 10% decline was calculated by dividing the number who had a decline of 10% TGs by the total number of participants in the arm.
Time Frame baseline, 24 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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia. Neither subject met criteria for virologic failure.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24. 
[Units: Percentage of patients]
 		 80   73 

No statistical analysis provided for Percentage of Patients That Experience 10% Decline in Triglycerides From Baseline to Week 24.



2.  Primary:   At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL   [ Time Frame: 24 weeks ]

Measure Type Primary
Measure Title At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL
Measure Description No text entered.
Time Frame 24 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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL 
[Units: Percentage of participants]
 		 48   55 

No statistical analysis provided for At Week 24 the Percentage of Subjects That Had Triglycerides Less Than 200 mg/dL



3.  Primary:   The Change in Fasting Triglyceride Level From Baseline to Week 24   [ Time Frame: Baseline to week 24 ]

Measure Type Primary
Measure Title The Change in Fasting Triglyceride Level From Baseline to Week 24
Measure Description No text entered.
Time Frame Baseline to week 24  

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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
The Change in Fasting Triglyceride Level From Baseline to Week 24 
[Units: mg/dL]
Mean (Full Range) 		 -126 
 (-312 to 133)  		 -88 
 (-469 to 90) 

No statistical analysis provided for The Change in Fasting Triglyceride Level From Baseline to Week 24



4.  Secondary:   Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24   [ Time Frame: Week 4, 12 & 24 ]

Measure Type Secondary
Measure Title Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24
Measure Description No text entered.
Time Frame Week 4, 12 & 24  

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
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   24 
Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24 
[Units: Percentage of participants]
 		   
Week 4   100   100 
Week 12   100   100 
Week 24   100   100 

No statistical analysis provided for Percent of Patients With HIV VL <200 Copies/mL at Week 4, 12 & 24



5.  Secondary:   Difference in CD4 From Baseline to Week 24   [ Time Frame: baseline to Week 24 ]

Measure Type Secondary
Measure Title Difference in CD4 From Baseline to Week 24
Measure Description No text entered.
Time Frame baseline to Week 24  

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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
Difference in CD4 From Baseline to Week 24 
[Units: Cells/mm^3]
Mean (Standard Error) 		 10.75  (17.67)   14.28  (19.77) 

No statistical analysis provided for Difference in CD4 From Baseline to Week 24



6.  Secondary:   Total Cholesterol in the Two Study Groups at 24 Weeks   [ Time Frame: Week 24 ]

Measure Type Secondary
Measure Title Total Cholesterol in the Two Study Groups at 24 Weeks
Measure Description No text entered.
Time Frame Week 24  

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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
Total Cholesterol in the Two Study Groups at 24 Weeks 
[Units: mg/dL]
Mean (Full Range) 		 195 
 (110 to 311)  		 195 
 (132 to 304) 

No statistical analysis provided for Total Cholesterol in the Two Study Groups at 24 Weeks



7.  Secondary:   LDL Cholesterol at Week 24   [ Time Frame: week 24 ]

Measure Type Secondary
Measure Title LDL Cholesterol at Week 24
Measure Description No text entered.
Time Frame week 24  

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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
LDL Cholesterol at Week 24 
[Units: mg/dL]
Mean (Full Range) 		 116 
 (55 to 180)  		 111 
 (46 to 204) 

No statistical analysis provided for LDL Cholesterol at Week 24



8.  Secondary:   HDL Cholesterol at Week 24   [ Time Frame: 24 weeks ]

Measure Type Secondary
Measure Title HDL Cholesterol at Week 24
Measure Description No text entered.
Time Frame 24 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.
Two patients in the ATV/r arm discontinued prior to week 24: 1 due to a grade 2 rash, and one due to low level viremia.

Reporting Groups
  Description
Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to DRV/r, 800mg/100mg QD
Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD Virologically suppressed patients on a regimen containing Lopinavir/ritonavir (LPV/r) or fosamprenavir/ritonavir (FPV/r) were switched to ATV/r

Measured Values
   Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD   Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD 
Participants Analyzed 
[Units: Participants]
 		 25   22 
HDL Cholesterol at Week 24 
[Units: mg/dL]
Mean (Full Range) 		 38 
 (22 to 54)  		 40 
 (26 to 55) 

No statistical analysis provided for HDL Cholesterol at Week 24




  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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Skiest
Organization: Community Research initiavte
phone: 413 794 5376
e-mail: Daniel.Skiest@baystatehealth.org



Responsible Party: Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00756730     History of Changes
Other Study ID Numbers: 08-09
First Submitted: September 18, 2008
First Posted: September 22, 2008
Results First Submitted: February 21, 2012
Results First Posted: July 13, 2012
Last Update Posted: August 21, 2017