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

This study has been completed.
Sponsor:
Collaborator:
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
Daniel Skiest, MD, Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00756730
First received: September 18, 2008
Last updated: October 23, 2012
Last verified: October 2012
Results First Received: February 21, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Interventions: Drug: ATV/r
Drug: DRV/r

  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
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
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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
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  
Number of Participants  
[units: participants]
  25     24     49  
Age, Customized  
[units: years]
Mean ( Full Range )
  48  
  ( 34 to 67 )  
  46  
  ( 30 to 60 )  
  47  
  ( 30 to 67 )  
Gender  
[units: participants]
     
Female     2     2     4  
Male     23     22     45  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     7     12     19  
Not Hispanic or Latino     18     11     29  
Unknown or Not Reported     0     1     1  
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  
[units: copies/mL]
  NA [1]   NA [1]   0  
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  
[1] VL was not detected. All values were reported less than 50 copies/ml, the lower limit of detection.



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

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

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

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

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

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

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


  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
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