Lopinavir/r or Fosamprenavir/r Switch to Atazanavir/r or Darunavir/r (LARD)
This study has been completed.
Sponsor:
Daniel Skiest, MD
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
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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
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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| No text entered. |
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 |
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 ] |
More Information
Certain Agreements:
Limitations and Caveats
Results Point of Contact:
No publications provided
| All Principal Investigators ARE employed by the organization sponsoring the study. |
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 |
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| No text entered. |
Results Point of Contact:
Name/Title: Dr. Daniel Skiest
Organization: Community Research initiavte
phone: 413 794 5376
e-mail: Daniel.Skiest@baystatehealth.org
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 |