This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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):
Community Research Initiative of New England
ClinicalTrials.gov Identifier:
NCT00756730
First received: September 18, 2008
Last updated: July 18, 2017
Last verified: July 2017
Results First Received: February 21, 2012  
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
  Hide 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


  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
  Hide 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