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 |
|---|
| 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
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
| 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| Time Frame | Baseline to 24 weeks |
|---|---|
| Additional Description | 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 |
Serious Adverse Events
| Switch to Darunavir/Ritonavir (DRV/r) , 800mg/100mg QD | Switch to Atazanavir/Ritonavir (ATV/r), 300mg/100mg QD | |
|---|---|---|
| Total, serious adverse events | ||
| # participants affected / at risk | 1/25 (4.00%) | 1/24 (4.17%) |
| Gastrointestinal disorders | ||
| possible bowel obstruction * | ||
| # participants affected / at risk | 0/25 (0.00%) | 1/24 (4.17%) |
| # events | 0 | 1 |
| Psychiatric disorders | ||
| alcohol withdrawal/suicidal Ideation * | ||
| # participants affected / at risk | 0/25 (0.00%) | 1/24 (4.17%) |
| # events | 0 | 1 |
| Renal and urinary disorders | ||
| urosepsis * | ||
| # participants affected / at risk | 1/25 (4.00%) | 0/24 (0.00%) |
| # events | 1 | 0 |
| * | Events were collected by non-systematic assessment |
|---|
Other Adverse Events
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 |
|---|
| 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 |