Phase 3
Completed N=443
Switching Nevirapine Immediate Release( IR) Based Regimen to Nevirapine Extended Release (XR) Based Regimen in Human Immunodeficiency Virus One (HIV-1) Infected Patients
Source: ClinicalTrials.gov NCT00819052 ↗Enrolled (actual)
443
Serious AEs
23.9%
Results posted
Feb 2012
Primary outcomePrimary: Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population — 137; 276; 11; 19 participants
Summary
The primary objective of this study is to demonstrate the efficacy of nevirapine extended release (NVP XR) based regimen for HIV-1 infected patients who were receiving nevirapine immediate release (NVP IR) based regimen for at least 18 prior weeks of therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Virologic Response at Week 24 Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population |
137; 276; 11; 19 | — |
| SECONDARY Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 400 Copies/mL, Full Analysis Set Population |
140; 285; 8; 10 | — |
| SECONDARY Kaplan-Meier Estimates of the Proportions of Patients Without Loss of Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population |
1; 1; 1; 0.986; 0.993; 0.98 | — |
| SECONDARY Summary of CD4 Count (Cells/Cubic Millimeter) at Baseline, Full Analysis Set Population |
569.7; 557.7 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 2, Observed Cases, Full Analysis Set Population |
3.7; -4.7 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 4, Observed Cases, Full Analysis Set Population |
0.8; -15.4 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 8, Observed Cases, Full Analysis Set Population |
-18.6; -24.4 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 12, Observed Cases, Full Analysis Set Population |
22.3; -10.2 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 24, Observed Cases, Full Analysis Set Population |
50.4; 45.7 | — |
| SECONDARY Comparison of CD4 Count (Cells/Cubic Millimeter) Change From Baseline at Week 24, Observed Cases, Full Analysis Set Population |
50.74; 46.10 | 0.7587 |
| SECONDARY Number of Participants With Virologic Response Using Lower Limit of Quantification (LLOQ) = 50 Copies/mL, Full Analysis Set Population |
121; 11; 261; 9; 2; 15 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 48, Observed Cases, Full Analysis Set Population |
77.8; 139.8; 52.7 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 60, Observed Cases, Full Analysis Set Population |
51.1; 11.5; 55.1 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 72, Observed Cases, Full Analysis Set Population |
61.3; 77.9; 67.4 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 84, Observed Cases, Full Analysis Set Population |
80.3; 134.6; 55.0 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 96, Observed Cases, Full Analysis Set Population |
55.1; 55.4; 60.2 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 108, Observed Cases, Full Analysis Set Population |
72.4; 117.4; 73.5 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 120, Observed Cases, Full Analysis Set Population |
79.5; 90.0; 66.6 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 132, Observed Cases, Full Analysis Set Population |
58.8; 124.8; 70.8 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Week 144, Observed Cases, Full Analysis Set Population |
85.3; 205.6; 82.7 | — |
| SECONDARY Change From Baseline in CD4 Count (Cells/Cubic Millimeter) at Last Available Visit, Observed Cases, Full Analysis Set Population |
71.9; 165.9; 80.9 | — |
| SECONDARY Proportion of Virologic Response (Viral Load <400 Copies/mL) Trough Week 144 |
121; 7; 250; 0; 0; 0 | — |
| SECONDARY Change From Baseline in VL (HIV-1 Viral Load) at Each Visit |
48.4; 58.4; -4.3; 11004.4; 94.1; -1.8 | — |
| SECONDARY Changes in Safety Parameters Related to Treatment |
1; 4; 0; 2; 1; 0 | — |
| SECONDARY Occurence of Rashes |
0; 1; 0; 1; 0; 0 | — |
| SECONDARY Occurence of Hepatic Events |
0; 1 | — |
| SECONDARY New AIDS or AIDS-related Progression Event or Death |
1; 2; 2; 2 | — |
| SECONDARY Time to Loss of Virologic Response |
393; 391 | — |
| SECONDARY Genotypic Resistance Associated With Virologic Failure |
— | — |
| SECONDARY Trough Plasma Concentration |
3720; NA; 3650; 3270; 3720; 3230 | — |
Eligibility Criteria
Inclusion criteria
HIV infected subjects treated with a Viramune based regimen.
A subject that meets the following inclusion criteria will be eligible for participation in this study:
- Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation.
- HIV-1 infected males or females of at least 18 years.
- Treatment with Viramune regimen for at least the preceding 18 weeks.
- Background therapy with lamivudine/ abacavir(3TC/ABC) (Kivexa® in EU; Epzicom in US), emtricitabine/tenofovir( FTC/TDF) (Truvada) or lamivudine/zidovudine 3TC/AZT (Combivir®).
- An HIV viral load DAIDS grade 2 Coagulation prothrombin time (PT), partial thromboplastin time (PTT), International Normalized ratio (INR) Hematology (absolute platelets, white blood cells (WBC), absolute neutrophil count, hemoglobin) Biochemistry (total bilirubin, amylase, serum creatinine, fasting glucose, lactate, alkaline phosphatase)
- Laboratory parameters > DAIDS grade 3 Total triglycerides (total cholesterol no restriction)
- Hypersensitivity to any ingredients of the test products
- Active drug abuse or chronic alcoholism.
- Hepatic cirrhosis stage Child-Pugh B or C
- History of severe or acute illness within 60 days prior to Day 1, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the trial
- Inability to comply with protocol requirements
Data sourced from ClinicalTrials.gov (NCT00819052). 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.