HIV Infections
Conditions
Brief summary
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.
Detailed description
Study Design: non-interventional uncontrolled observational study
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
1. HIV-1 infected male and female 18 years and above; 2. anti-retroviral therapy (ART) naive and pre-treated patients switching from a nevirapine immediate release or other ART.
Exclusion criteria
Consistent with the current VIRAMUNE prolonged release SPC.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | up to 72 weeks | 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. |
| Number of Patients Reporting Rash of Any Severity | up to 72 weeks | Number of patients reporting rash of any severity as adverse event |
| Number of Patients Reporting Hepatic Events | up to 72 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | 24 weeks | 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. |
| Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | 24 weeks | The number of patients reporting that they find the once daily nevirapine intake more / very much more convenient than the twice daily formulation. |
| Change in CD4+ Cell Count From Baseline to Week 24 | baseline and 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. |
| Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | baseline and week 24 | 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. |
Countries
Austria, Poland, Romania
Participant flow
Recruitment details
387 patients started treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment-naive Patients Patients who were not pretreated with HIV therapy | 49 |
| Patients Switching From Nevirapine IR Patients switching from nevirapine immediate release (IR). | 246 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL. | 30 |
| Pretreated Patients, Baseline Viral Load>50 Copies/mL Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load \> 50 copies/mL. | 22 |
| Patients With Baseline Viral Load Not Documented Patients with no documented information about the baseline viral load. | 40 |
| Total | 387 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 12 | 1 | 0 | 0 |
| Overall Study | No reason documented | 2 | 1 | 0 | 1 | 0 |
| Overall Study | Other reason than stated above | 1 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Continuous | 34.9 years STANDARD_DEVIATION 9.9 | 39.8 years STANDARD_DEVIATION 13.8 | 38.1 years STANDARD_DEVIATION 11.1 | 33.1 years STANDARD_DEVIATION 10.4 | 37.4 years STANDARD_DEVIATION 13.2 | 38.5 years STANDARD_DEVIATION 13.1 |
| Gender Female | 8 participants | 90 participants | 11 participants | 7 participants | 19 participants | 135 participants |
| Gender Male | 41 participants | 155 participants | 19 participants | 14 participants | 21 participants | 250 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 246 | 0 / 30 | 0 / 22 | 0 / 40 |
| serious Total, serious adverse events | 0 / 49 | 2 / 246 | 0 / 30 | 0 / 22 | 0 / 40 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients Reporting Hepatic Events | Hepatic events reported as AE | 0 participants |
| Treatment-naive Patients | Number of Patients Reporting Hepatic Events | Abnormality in ALT | 11 participants |
| Treatment-naive Patients | Number of Patients Reporting Hepatic Events | Abnormality in Bilirubin | 4 participants |
| Treatment-naive Patients | Number of Patients Reporting Hepatic Events | Abnormality in AST | 1 participants |
| Treatment-naive Patients | Number of Patients Reporting Hepatic Events | Abnormality in Gamma-GT | 11 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Hepatic Events | Abnormality in AST | 3 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Hepatic Events | Abnormality in Gamma-GT | 64 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Hepatic Events | Abnormality in ALT | 22 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Hepatic Events | Hepatic events reported as AE | 0 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Hepatic Events | Abnormality in Bilirubin | 3 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in Bilirubin | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Hepatic Events | Hepatic events reported as AE | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in AST | 1 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in ALT | 7 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in Gamma-GT | 7 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in AST | 4 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Hepatic Events | Hepatic events reported as AE | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in Gamma-GT | 5 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in Bilirubin | 1 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Hepatic Events | Abnormality in ALT | 9 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Hepatic Events | Abnormality in Gamma-GT | 4 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Hepatic Events | Hepatic events reported as AE | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Hepatic Events | Abnormality in Bilirubin | 1 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Hepatic Events | Abnormality in ALT | 8 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Hepatic Events | Abnormality in AST | 1 participants |
Primary
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
Population: Patients from TS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients reporting non-serious adverse events | 0 participants |
| Treatment-naive Patients | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with serious adverse events | 0 participants |
| Treatment-naive Patients | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with nSAEs leading to discontinuation | 0 participants |
| Treatment-naive Patients | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with SAEs leading to discontinuation | 0 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients reporting non-serious adverse events | 4 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with SAEs leading to discontinuation | 0 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with serious adverse events | 2 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with nSAEs leading to discontinuation | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with SAEs leading to discontinuation | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with serious adverse events | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with nSAEs leading to discontinuation | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients reporting non-serious adverse events | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients reporting non-serious adverse events | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with serious adverse events | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with SAEs leading to discontinuation | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with nSAEs leading to discontinuation | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with SAEs leading to discontinuation | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with nSAEs leading to discontinuation | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients with serious adverse events | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Non-serious Adverse Events, Serious Adverse Events, and Non-serious and Serious Adverse Events Leading to Treatment Discontinuation | Patients reporting non-serious adverse events | 0 participants |
Primary
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
Population: Patients TS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive Patients | Number of Patients Reporting Rash of Any Severity | 0 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Rash of Any Severity | 0 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Rash of Any Severity | 0 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Rash of Any Severity | 0 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Rash of Any Severity | 0 participants |
Secondary
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
Population: Patients from FAS with documented CD4+ at baseline and after 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Change in CD4+ Cell Count From Baseline to Week 24 | 19.6 cells/mm^3 | Standard Deviation 347.8 |
| Patients Switching From Nevirapine IR | Change in CD4+ Cell Count From Baseline to Week 24 | 98.9 cells/mm^3 | Standard Deviation 199.7 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Change in CD4+ Cell Count From Baseline to Week 24 | 73.5 cells/mm^3 | Standard Deviation 152.2 |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Change in CD4+ Cell Count From Baseline to Week 24 | 31.2 cells/mm^3 | Standard Deviation 148.4 |
| Patients With Baseline Viral Load Not Documented | Change in CD4+ Cell Count From Baseline to Week 24 | 135.9 cells/mm^3 | Standard Deviation 583.5 |
Secondary
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
Population: Patients from FAS with documented MMAS-8 score at baseline and after 24 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment-naive Patients | Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 0.3 units on a scale | Standard Deviation 1.1 |
| Patients Switching From Nevirapine IR | Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 0.4 units on a scale | Standard Deviation 1.2 |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 0.7 units on a scale | Standard Deviation 1.2 |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | 0.8 units on a scale | Standard Deviation 2.1 |
| Patients With Baseline Viral Load Not Documented | Change in Morisky Medication Adherence Scale Score From Baseline to 24 Weeks | -0.1 units on a scale | Standard Deviation 1.2 |
Secondary
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
Population: Patients from FAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is more convenient | 4 participants |
| Treatment-naive Patients | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is very much more convenient | 29 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is more convenient | 41 participants |
| Patients Switching From Nevirapine IR | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is very much more convenient | 105 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is more convenient | 6 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is very much more convenient | 17 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is very much more convenient | 14 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is more convenient | 4 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is more convenient | 7 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients Reporting Once Daily Nevirapine Intake More Convenient Than Twice Daily Formulation | Once daily intake is very much more convenient | 26 participants |
Secondary
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
Population: Patients from the Full analysis set (FAS): This patient set includes all patients in the treated set who have analysable data in at least one efficacy endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive Patients | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Virologic response | 21 participants |
| Treatment-naive Patients | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Missing | 16 participants |
| Treatment-naive Patients | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | No virologic response | 3 participants |
| Patients Switching From Nevirapine IR | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | No virologic response | 10 participants |
| Patients Switching From Nevirapine IR | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Virologic response | 150 participants |
| Patients Switching From Nevirapine IR | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Missing | 63 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | No virologic response | 1 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Virologic response | 15 participants |
| Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Missing | 13 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Virologic response | 3 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Missing | 16 participants |
| Pretreated Patients, Baseline Viral Load >50 Copies/mL | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | No virologic response | 2 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | No virologic response | 1 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Virologic response | 11 participants |
| Patients With Baseline Viral Load Not Documented | Number of Patients With Virologic Response at Week 24 (Viral Load <50 Copies/mL) | Missing | 25 participants |