HIV Infections
Conditions
Brief summary
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Viramune® on a background of different antiretroviral drug combinations.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria follow the same criteria which are describe in the newest SPC.
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Reporting Adverse Events | 48 weeks | the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Response (VR) | 48 weeks | VR was defined as Human immunodeficiency virus (HIV) viral load of \<50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by 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 was defined as a permanent discontinuation of Nevirapine. |
| Change in CD4+ Cell Count From Baseline to Week 48 | Baseline and week 48 | Calculated as CD4+ cell count at week 48 minus the baseline value |
Countries
Austria, Poland
Participant flow
Recruitment details
There were 280 patients enrolled but two patients were lost to follow up before the second visit (2 weeks). For these two patients no information about Nevirapine intake could be assessed. So they were not included in the treated set which was used for most of the analyses.
Pre-assignment details
This was an observational, non-interventional, uncontrolled, prospective post marketing study.
Participants by arm
| Arm | Count |
|---|---|
| Nevirapine Patients treated with 200 mg Nevirapine twice daily (administered orally). | 278 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 22 |
| Overall Study | Lack of Efficacy | 16 |
| Overall Study | Lost to Follow-up | 27 |
Baseline characteristics
| Characteristic | Nevirapine |
|---|---|
| Age, Continuous | 38.5 Years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 219 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 278 |
| serious Total, serious adverse events | 12 / 278 |
Outcome results
Primary
Proportion of Patients Reporting Adverse Events
the incidence of non serious adverse events and serious adverse events according to body system (= System Organ Class) and preferred term.
Time frame: 48 weeks
Population: The treated Set (TS), defined as all patients reported to have received at least one dose of Nevirapine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine | Proportion of Patients Reporting Adverse Events | rash, any severity | 3.2 Percentage of participants |
| Nevirapine | Proportion of Patients Reporting Adverse Events | hepatic events, any severity | 3.2 Percentage of participants |
| Nevirapine | Proportion of Patients Reporting Adverse Events | any event | 25.5 Percentage of participants |
| Nevirapine | Proportion of Patients Reporting Adverse Events | serious adverse events | 4.3 Percentage of participants |
| Nevirapine | Proportion of Patients Reporting Adverse Events | adverse events leading to discontinuation | 9.7 Percentage of participants |
| Nevirapine | Proportion of Patients Reporting Adverse Events | Central Nervous system side effects, any severity | 3.6 Percentage of participants |
Secondary
Change in CD4+ Cell Count From Baseline to Week 48
Calculated as CD4+ cell count at week 48 minus the baseline value
Time frame: Baseline and week 48
Population: TS with non-missing data at baseline and week 48
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nevirapine | Change in CD4+ Cell Count From Baseline to Week 48 | 148.5 Cells/mm^3 | Standard Deviation 154.6 |
Secondary
Virologic Response (VR)
VR was defined as Human immunodeficiency virus (HIV) viral load of \<50 copies/mL before week 48 and without any subsequent rebound or change of Antiretroviral (ARV) therapy. A rebound was defined by 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 was defined as a permanent discontinuation of Nevirapine.
Time frame: 48 weeks
Population: TS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Nevirapine | Virologic Response (VR) | with VR | 139 Participants |
| Nevirapine | Virologic Response (VR) | without VR | 16 Participants |
| Nevirapine | Virologic Response (VR) | missing | 123 Participants |