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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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


  Outcome Measures
  Show All Outcome Measures

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 ]

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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  More Information
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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


No publications provided


Responsible Party: Daniel Skiest, MD, Community Research Initiative of New England
ClinicalTrials.gov Identifier: NCT00756730     History of Changes
Other Study ID Numbers: 08-09
Study First Received: September 18, 2008
Results First Received: February 21, 2012
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration