Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
This study has been completed.
Sponsor:
Tibotec, Inc
Collaborator:
Tibotec Therapeutics, a Division of Ortho Biotech Products, L.P., USA
Information provided by (Responsible Party):
Tibotec, Inc
ClinicalTrials.gov Identifier:
NCT00460746
First received: April 13, 2007
Last updated: July 24, 2013
Last verified: July 2013
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Results First Received: October 2, 2009
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment |
| Condition: |
HIV |
| Intervention: |
Drug: TMC125, Darunavir; Ritonavir |
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 |
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| No text entered. |
Reporting Groups
| Description | |
|---|---|
| Darunavir(TMC114)/Eravirine(TMC125) | Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF. |
Participant Flow: Overall Study
| Darunavir(TMC114)/Eravirine(TMC125) | |
|---|---|
| STARTED | 10 |
| COMPLETED | 8 |
| NOT COMPLETED | 2 |
| Adverse Event | 1 |
| Lost to Follow-up | 1 |
Baseline Characteristics
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 | |
|---|---|
| Darunavir(TMC114)/Eravirine(TMC125) | Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF. |
Baseline Measures
| Darunavir(TMC114)/Eravirine(TMC125) | |
|---|---|
|
Number of Participants
[units: participants] |
10 |
|
Age
[units: years] Median ( Full Range ) |
48
( 35 to 61 ) |
|
Gender
[units: participants] |
|
| Female | 0 |
| Male | 10 |
|
Race/Ethnicity, Customized
[units: participants] |
|
| White | 6 |
| Hispanic | 4 |
|
Viral Load <50 copies/mL
[units: participants] |
10 |
|
CD4 count
[units: cells/mm^3] Median ( Full Range ) |
301
( 187 to 663 ) |
Outcome Measures
Show All Outcome Measures
| 1. Primary: | Proportion of Patients Who Maintain Plasma HIV Viral Load Measurements < 400 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure. [ Time Frame: 48 weeks ] |
| 2. Secondary: | Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure. [ Time Frame: 48 weeks ] |
Hide Outcome Measure 2
| Measure Type | Secondary |
|---|---|
| Measure Title | Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure. |
| Measure Description | No text entered. |
| Time Frame | 48 weeks |
| 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. |
|---|
| ITT population. One subject (001) who discontinued due to adverse events had a VL < 50 copies/mL at Week 4. Another subject (013) who was lost to follow-up had VL <50 copies/mL through Week 36. |
Reporting Groups
| Description | |
|---|---|
| Darunavir(TMC114)/Eravirine(TMC125) | Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF. |
Measured Values
| Darunavir(TMC114)/Eravirine(TMC125) | |
|---|---|
|
Number of Participants Analyzed
[units: participants] |
10 |
|
Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.
[units: percentage of participants] |
|
| Baseline (Day 1) | 100 |
| Week 2 | 90 |
| Week 4 | 90 |
| Week 8 | 90 |
| Week 12 | 80 |
| Week 16 | 90 |
| Week 24 | 90 |
| Week 36 | 90 |
| Week 48 | 80 |
| Post-Treatment Follow Up | 90 |
No statistical analysis provided for Proportion of Patients Who Have Viral Load Measurements <50 Copies/ml at 2, 4, 8, 12, 16, 24, 36 and 48 Weeks After Switching to DRV/r and ETR, Missing Equals Failure.
| 3. Secondary: | CD4+ Cell Count (x 10^6 Cell/L): Baseline and Median Changes From Baseline at 4, 8, 12, 16, 24, 36 and 48 Weeks. [ Time Frame: Week 48 ] |
| 4. Secondary: | CD4+ Cell Count (x 10^6 Cell/L): Baseline and Mean Changes From Baseline at 4, 8, 12, 16, 24,36 and 48 Weeks. [ Time Frame: Week 48 ] |
| 5. Secondary: | Median Change From Baseline in Triglycerides at Week 48. [ Time Frame: Week 48 ] |
| 6. Secondary: | Median Change From Baseline in Total Cholesterol at Week 48. [ Time Frame: Week 48 ] |
| 7. Secondary: | Median Change From Baseline in LDL Cholesterol at Week 48. [ Time Frame: Week 48 ] |
| 8. Secondary: | Median Change From Baseline in HDL Cholesterol. [ Time Frame: Week 48 ] |
| 9. Secondary: | Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48. [ Time Frame: Week 48 ] |
| 10. Secondary: | Median Change From Baseline in Glucose at Week 48. [ Time Frame: Week 48 ] |
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 |
|---|
| Conclusions on efficacy and safety are limited as the target enrollment of 40 subjects was not reached due to a shortage of eligible subjects. |