N/A
Completed N=265
Non-interventional Observational Study With Viramune® in HIV to Evaluate Gender Specific Data
Source: ClinicalTrials.gov NCT01134939 ↗Enrolled (actual)
265
Serious AEs
8.3%
Results posted
Jan 2015
Primary outcomePrimary: Number of Patients With Virologic Response (VR) After 36 Months — 44; 30; 46; 40 participants
Summary
The question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). First and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with Viramune and other antiretroviral partners. In particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the CD4 cell count.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Virologic Response (VR) After 36 Months |
44; 30; 46; 40; 25; 6 | — |
| SECONDARY Changes in the Viral Load After 36 Months From Baseline |
-2.7; -2.7; -0.3; -0.3; -2.4; -1.2 | — |
| SECONDARY Changes in the CD4+ Cell Count After 36 Months From Baseline |
253.3; 216.9; 85.9; 39.8; 246.4; 137.1 | — |
| SECONDARY Changes in the Laboratory Data (Total Cholesterol) After 36 Months From Baseline |
3.9; 32.9; -11.5; 43.0; -2.0; 26.0 | — |
| SECONDARY Changes in the Laboratory Data (HDL Cholesterol) After 36 Months From Baseline |
15.6; 20.2; 9.3; -26.5; 18.9; 5.0 | — |
| SECONDARY Changes in the Laboratory Data (LDL Cholesterol) After 36 Months From Baseline |
5.3; 27.8; 3.8; 5.0; -9.3; 73.0 | — |
| SECONDARY Changes in the Laboratory Data (Triglycerides) After 36 Months From Baseline |
-18.5; -16.6; -71.8; -31.7; -53.3; 160 | — |
| SECONDARY Changes in the Laboratory Data (Blood Glucose) After 36 Months From Baseline |
2.4; 5.3; 0.2; 3.9; 7.2; -27.5 | — |
| SECONDARY Changes in the Laboratory Data ( ALT) After 36 Months From Baseline |
1.3; 7.5; 7.7; 6.1; 0.0; 12.6 | — |
| SECONDARY Changes in the Laboratory Data (AST) After 36 Months From Baseline |
1.4; 3.0; 1.4; 0.4; -1.7; -0.8 | — |
| SECONDARY Changes in the Laboratory Data (Gamma-GT) After 36 Months From Baseline |
22.7; 25.2; 7.0; 4.8; 20.9; 40.8 | — |
| SECONDARY Changes in the Laboratory Data (Creatinine) After 36 Months From Baseline |
0.0; 0.1; -0.1; -0.1; 0.0; -0.1 | — |
| SECONDARY Changes in the Laboratory Data (Haemoglobin) After 36 Months From Baseline |
0.8; 0.4; 0.1; 0.8; 1.1; 1.0 | — |
Eligibility Criteria
Inclusion criteria
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC
Exclusion criteria
The inclusion criteria for treatment with Viramune plus other antiretroviral combination drugs are to be based on the current Information for Healthcare Professionals/SPC
Data sourced from ClinicalTrials.gov (NCT01134939). 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.