Phase 3
Completed N=10
Enfuvirtide/Current Protease Inhibitor Switch to PREZISTA (Darunavir)/Ritonavir + TMC125 in HIV Patients With Enfuvirtide Side Effects.
Source: ClinicalTrials.gov NCT00460746 ↗Enrolled (actual)
10
Serious AEs
10.0%
Results posted
Nov 2009
Primary outcomePrimary: 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. — 100; 100; 100; 90 percentage of participants
Summary
The purpose of this study is to examine the safety, tolerability, and effectiveness of darunavir/ritonavir combined with TMC125 when current protease inhibitor(s), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI(s)) and enfuvirtide are replaced by darunavir/ritonavir and TMC125 in HIV positive patients who can no longer tolerate enfuvirtide and are experiencing viral suppression. Other antiviral drugs in the regimen are to remain unchanged.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
100; 100; 100; 90; 80; 90 | — |
| 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. |
100; 90; 90; 90; 80; 90 | — |
| 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. |
301.0; -12.0; -32.0; -17.0; -7.0; 19.0 | — |
| 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. |
338.3; 2.3; -25.0; -18.9; 0.5; 24.5 | — |
| SECONDARY Median Change From Baseline in Triglycerides at Week 48. |
229.0; -24.5 | — |
| SECONDARY Median Change From Baseline in Total Cholesterol at Week 48. |
189.0; -27.5 | — |
| SECONDARY Median Change From Baseline in LDL Cholesterol at Week 48. |
100.0; -9.0 | — |
| SECONDARY Median Change From Baseline in HDL Cholesterol. |
47.5; -2.5 | — |
| SECONDARY Median Change From Baseline in Total Cholesterol (TC) / High Denisty Lipoprotein (HDL) Ratio at Week 48. |
4.7; -0.3 | — |
| SECONDARY Median Change From Baseline in Glucose at Week 48. |
92.5; 1.0 | — |
Eligibility Criteria
Inclusion Criteria
- Documented HIV-1 positive
- History of drug resistance or antiretroviral failure while receiving each of three drug classes: Nucleoside Reverse Transcriptase Inhibitors (NRTIs), Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) and (protease inhibitors) PIs
- On a PI containing regimen with enfuvirtide with HIV viral load (VL) 3 darunavir resistance-associated mutations with available darunavir phenotypes, may be enrolled if the resistance phenotype demonstrates: Fold Change (FC) 5 times ULN
- Calculated CrCl < 30 ml/min.
Data sourced from ClinicalTrials.gov (NCT00460746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.