HIV Infections
Conditions
Brief summary
This observational study is supposed to assess (under conditions of clinical practice in daily routine) whether treatment with Viramune (nevirapine) in combination with Truvada (tenofovir and emtricitabine) will durably suppress viral load below the limit of detection or will maintain suppression of viral replication (HIV-RNA below limit of detection) achieved under previous anti-retroviral combination therapy after switch to combination treatment of Viramune (nevirapine) and Truvada (tenofovir and emtricitabine).
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
* male and female adult HIV type 1 infected patients, who have either not been treated previously, whose previous combination treatment with PIs has failed, or who have to switch their previous treatment from protease inhibitors (PI) or non-nucleoside reverse transcriptase inhibitors (NNRT)I due to side effects or intolerability after achieving suppression of viral load below the limit of detection. * Viramune (nevirapine) is indicated as part of combination therapy for the antiviral treatment of HIV-1 infected patients with advanced or progressive immunodeficiency. * Truvada (tenofovir and emtricitabine) is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.
Exclusion criteria
* Age \< 18 years * Pregnant female patients * Hypersensitivity to the active substance or to any of the excipients of Viramune (nevirapine) or Truvada (tenofovir and emtricitabine). * Viramune (nevirapine) should not be readministered to patients who have required permanent discontinuation for severe rash, rash accompanied by constitutional symptoms, hypersensitivity reactions, or clinical hepatitis due to nevirapine. * Viramune (nevirapine) should not be used in patients with severe hepatic impairment (Child-Pugh C) or pre-treatment aspartine transaminase (ASAT) or alanine transaminase (ALAT) \> 5 upper limit normal (ULN) until baseline ASAT/ALAT are stabilised \< 5 ULN. * Viramune (nevirapine) should not be readministered in patients who previously had ASAT or ALAT \> 5 ULN during Viramune (nevirapine) therapy and had recurrence of liver function abnormalities upon readministration of Viramune (nevirapine) * Herbal preparations containing St Johns wort (Hypericum perforatum) must not be used while taking Viramune (nevirapine) due to the risk of decreased plasma concentrations and reduced clinical effects of nevirapine * The available pharmacokinetic data suggest that the concomitant use of rifampicin and Viramune (nevirapine) is not recommended.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Change From Baseline in Glucose to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in Glucose from baseline to the last value in treatment |
| Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in total cholesterol from baseline to the last value in treatment |
| Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment |
| Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment |
| Summary of Change From Baseline in Triglycerides to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in triglycerides from baseline to the last value in treatment |
| Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in alanine aminotransferase (ALT) from baseline to the last value in treatment |
| Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in asparate aminotransferase (AST) from baseline to the last value in treatment |
| Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment |
| Summary of Change From Baseline in Creatinine to Last Value on Treatment | from baseline to last value on treatment in between 36 months | The change in Creatinine from baseline to the last value in treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Change From Baseline in CD4+ Count to Last Value on Treatment | from baseline to last value on treatment in between 36 months | — |
| Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator | from baseline to last value on treatment in between 36 months | Total number of patients with investigator defined non-serious drug-related AEs was reported. |
| Investigator's Global Clinical Assessment of Patient General Health Status | from baseline to last value on treatment in between 36 months | Investigators opinion of patients general health condition at baseline versus last evaluation on treatment |
| Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment | from baseline to last value on treatment in between 36 months | For calculation of this measure switch patients are included in the total which had no viral load decrease. |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With Viramune in Combination With Truvada Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd | 334 |
| Total | 334 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Lack of Efficacy | 22 |
| Overall Study | Lost to Follow-up | 20 |
| Overall Study | Other | 86 |
Baseline characteristics
| Characteristic | Patients Treated With Viramune in Combination With Truvada |
|---|---|
| Age, Continuous | 41.8 Years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 276 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 19 / 334 |
| serious Total, serious adverse events | 19 / 334 |
Outcome results
Primary
Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment
The change in alanine aminotransferase (ALT) from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Alanine Aminotransferase (ALT) to Last Value on Treatment | 1.0 IU/L |
Primary
Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment
The change in asparate aminotransferase (AST) from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Asparate Aminotransferase (AST) to Last Value on Treatment | 4.0 IU/L |
Primary
Summary of Change From Baseline in Creatinine to Last Value on Treatment
The change in Creatinine from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Creatinine to Last Value on Treatment | 0.0 mg/dl |
Primary
Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment
The change in Gamma-glutamyl transferase (Gamma-GT) from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Gamma-glutamyl Transferase (Gamma-GT) to Last Value on Treatment | 23.0 IU/L |
Primary
Summary of Change From Baseline in Glucose to Last Value on Treatment
The change in Glucose from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Glucose to Last Value on Treatment | 0.0 mg/dl |
Primary
Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment
The change in High-density lipoprotein (HDL) cholesterol from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in High-density Lipoprotein (HDL) Cholesterol to Last Value on Treatment | 6.0 mg/dl |
Primary
Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment
The change in Low-density lipoprotein (LDL) cholesterol from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Low-density Lipoprotein (LDL) Cholesterol to Last Value on Treatment | 5.0 mg/dl |
Primary
Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment
The change in total cholesterol from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Total Cholesterol to Last Value on Treatment | 12.0 mg/dl |
Primary
Summary of Change From Baseline in Triglycerides to Last Value on Treatment
The change in triglycerides from baseline to the last value in treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in Triglycerides to Last Value on Treatment | -7.0 mg/dl |
Secondary
Investigator's Global Clinical Assessment of Patient General Health Status
Investigators opinion of patients general health condition at baseline versus last evaluation on treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Investigator's Global Clinical Assessment of Patient General Health Status | Bad | 10 participants |
| Patients Treated With Viramune in Combination With Truvada | Investigator's Global Clinical Assessment of Patient General Health Status | Missing | 4 participants |
| Patients Treated With Viramune in Combination With Truvada | Investigator's Global Clinical Assessment of Patient General Health Status | Good | 193 participants |
| Patients Treated With Viramune in Combination With Truvada | Investigator's Global Clinical Assessment of Patient General Health Status | Moderate | 127 participants |
| Last Evaluation Assessment on Treatment | Investigator's Global Clinical Assessment of Patient General Health Status | Moderate | 49 participants |
| Last Evaluation Assessment on Treatment | Investigator's Global Clinical Assessment of Patient General Health Status | Bad | 4 participants |
| Last Evaluation Assessment on Treatment | Investigator's Global Clinical Assessment of Patient General Health Status | Good | 273 participants |
| Last Evaluation Assessment on Treatment | Investigator's Global Clinical Assessment of Patient General Health Status | Missing | 8 participants |
Secondary
Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator
Total number of patients with investigator defined non-serious drug-related AEs was reported.
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Number of Patients With Non-serious Drug-related AEs as Judged by the Investigator | 57 participants |
Secondary
Summary of Change From Baseline in CD4+ Count to Last Value on Treatment
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Change From Baseline in CD4+ Count to Last Value on Treatment | 141 (cells) / mm^3 |
Secondary
Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment
For calculation of this measure switch patients are included in the total which had no viral load decrease.
Time frame: from baseline to last value on treatment in between 36 months
Population: FAS- All patients were considered for the full analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Patients Treated With Viramune in Combination With Truvada | Summary of Log10 Change From Baseline in Viral Load to Last Value on Treatment | -2.3 (log10 copies) / ml |