An observational study in HIV Infections, sponsored by Boehringer Ingelheim. Completed at 53 sites in 3 countries. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Boehringer Ingelheim · Observational
This Post Marketing Surveillance study will be performed as an open-label, prospective, non-interventional, uncontrolled study in Human immunodeficit Virus-1 (HIV-1) infected patients. Data will only be documented in patients for whom a pharmacotherapy with nevirapine extended release is initiated. Both anti-retroviral therapy (ART) naïve patients and pre-treated patients switching from nevirapine immediate release or other anti-retroviral therapy (ART) will be included in the study. The decision to initiate treatment with nevirapine extended release is independent of this study and is based entirely on individual patient need and the judgement of the treating physician. The aim of the study is to assess the safety and efficacy and treatment adherence of nevirapine extended release in HIV-1 infected patients in routine clinical practice. It is planned to document five visits for each patient over a twenty four week observational period.
Study Design:
non-interventional uncontrolled observational study
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 398 is above the median of 200 across 713 observational studies indexed under HIV Infections.
Browse HIV Infections studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
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HIV-1 infected patients
Exclusion criteria:
Consistent with the current VIRAMUNE prolonged release SPC.
Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
Time frame: up to 72 weeks
Number of Patients Reporting Rash of Any Severity
Number of patients reporting rash of any severity as adverse event
Time frame: up to 72 weeks
Number of Patients Reporting Hepatic Events
Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.
Time frame: up to 72 weeks
Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL)
Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of \< 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.
Time frame: 24 weeks
Change in CD4+ Cell Count From Baseline to Week 24
The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.
Time frame: baseline and week 24
Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks
The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
Time frame: baseline and week 24
Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation
The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.
Time frame: 24 weeks
387 patients started treatment.
| Milestone | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Started | 49 | 246 | 30 | 22 | 40 |
| Completed | 43 | 232 | 29 | 21 | 40 |
| Not completed | 6 | 14 | 1 | 1 | 0 |
| Withdrew: Lost to follow-up | 3 | 12 | 1 | 0 | 0 |
| Withdrew: Other reason than stated above | 1 | 1 | 0 | 0 | 0 |
| Withdrew: No reason documented | 2 | 1 | 0 | 1 | 0 |
The primary endpoint is to evaluate the safety of a highly active antiretroviral therapy (HAART) that includes nevirapine extended release in routine clinical practice which is to assess the number of patients reporting non-serious adverse events (nSAEs), the number of patients with serious adverse events (SAE), the number of patients with non-serious adverse events leading to treatment discontinuation, and the number of patients with serious adverse events leading to discontinuation.
| participants | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Patients reporting non-serious adverse events | 0 | 4 | 0 | 0 | 0 |
| Patients with serious adverse events | 0 | 2 | 0 | 0 | 0 |
| Patients with nSAEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 |
| Patients with SAEs leading to discontinuation | 0 | 0 | 0 | 0 | 0 |
Virologic response is defined as confirmed Human Immunodeficiency Virus (HIV) viral load of \< 50 copies/mL (at two consecutive measurements after baseline) up to week 24 and without subsequent rebound or change of anti-retroviral (ARV) therapy up to week 24. A rebound is defined as two consecutive measurements of viral load (VL) ≥ 50 copies/mL, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/mL. A change of ARV therapy is defined as a permanent discontinuation of nevirapine extended release, addition of new ARV drugs, or alteration in background therapy. A change in the background therapy due to toxicity or intolerance is not considered as treatment failure. If no follow-up viral load was available the virologic response is Missing.
| participants | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Virologic response | 21 | 150 | 15 | 3 | 11 |
| No virologic response | 3 | 10 | 1 | 2 | 1 |
| Missing | 16 | 63 | 13 | 16 | 25 |
The change in the Cluster of differentiation 4 (CD4+) cell count from baseline after 24 weeks was calculated by subtracting the baseline value from the value after 24 weeks. Therefore, a positive change represents an increase in CD4+ cell count.
| cells/mm^3 | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Change in CD4+ Cell Count From Baseline to Week 24 | 19.6 ± 347.8 | 98.9 ± 199.7 | 73.5 ± 152.2 | 31.2 ± 148.4 | 135.9 ± 583.5 |
The Morisky Medication Adherence scale (MMAS-8 scale) is a recognized indicator of medication adherence, consisting of 8 questions with a sum score ranging between 0 and 8 points. The higher score indicates higher adherence to the prescribed therapy recommendation. It has been agreed that the score of 8 could be categorized as having high adherence, score between 6 and 7 as medium adherence and scores of 5 and less as low adherence. The change is presented as the score after 24 weeks minus the score at baseline. Therefore, a positive change score reflects an improvement in the adherence.
| units on a scale | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 0.3 ± 1.1 | 0.4 ± 1.2 | 0.7 ± 1.2 | 0.8 ± 2.1 | -0.1 ± 1.2 |
The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation.
| participants | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load >50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Once daily intake is more convenient | 4 | 41 | 6 | 4 | 7 |
| Once daily intake is very much more convenient | 29 | 105 | 17 | 14 | 26 |
Number of patients reporting rash of any severity as adverse event
| participants | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load>50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Number of Patients Reporting Rash of Any Severity | 0 | 0 | 0 | 0 | 0 |
Number of patients reporting hepatic events either as adverse event (AE) or as laboratory abnormality of Grade 1 to Grade 4 in aspartate aminotransferase (AST), alanine transaminase (ALT), Gamma-Glutamyl-Transferase (Gamma-GT) and bilirubin.
| participants | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load>50 Copies/mL | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Hepatic events reported as AE | 0 | 0 | 0 | 0 | 0 |
| Abnormality in AST | 1 | 3 | 1 | 4 | 1 |
| Abnormality in ALT | 11 | 22 | 7 | 9 | 8 |
| Abnormality in Gamma-GT | 11 | 64 | 7 | 5 | 4 |
| Abnormality in Bilirubin | 4 | 3 | 0 | 1 | 1 |
Collected over Up to 72 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment-naïve Patients | — | 0/49 (0%) | 0/49 (0%) |
| Patients Switching From Nevirapine IR | — | 2/246 (0.8%) | 0/246 (0%) |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML | — | 0/30 (0%) | 0/30 (0%) |
| Pretreated Patients, Baseline Viral Load > 50 Copies/ML | — | 0/22 (0%) | 0/22 (0%) |
| Patients With Baseline Viral Load Not Documented | — | 0/40 (0%) | 0/40 (0%) |
| Event | Treatment-naïve Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML | Pretreated Patients, Baseline Viral Load > 50 Copies/ML | Patients With Baseline Viral Load Not Documented |
|---|---|---|---|---|---|
| Coronary artery disorderCardiac disorders | 0/49 | 1/246 | 0/30 | 0/22 | 0/40 |
| DiarrhoeaGastrointestinal disorders | 0/49 | 1/246 | 0/30 | 0/22 | 0/40 |
| GastroenteritisGastrointestinal disorders | 0/49 | 1/246 | 0/30 | 0/22 | 0/40 |
Patients from the Treated Set (TS): This patient set includes all HIV-1 infected patients who were dispensed Viramune® and were documented to have taken at least one dose of Viramune®and of a antiretroviral combination partner.
| Age, Continuous(years) | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load>50 Copies/mL | Patients With Baseline Viral Load Not Documented | Total |
|---|---|---|---|---|---|---|
| Mean | 34.9 ± 9.9 | 39.8 ± 13.8 | 38.1 ± 11.1 | 33.1 ± 10.4 | 37.4 ± 13.2 | 38.5 ± 13.1 |
| Gender(participants) | Treatment-naive Patients | Patients Switching From Nevirapine IR | Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Pretreated Patients, Baseline Viral Load>50 Copies/mL | Patients With Baseline Viral Load Not Documented | Total |
|---|---|---|---|---|---|---|
| Female | 8 | 90 | 11 | 7 | 19 | 135 |
| Male | 41 | 155 | 19 | 14 | 21 | 250 |
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Boehringer Ingelheim