HIV Infections
Conditions
Brief summary
To obtain information on clinical practices for patients treated by Aptivus in real life
Interventions
DRUGtipranavir
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* HIV positive patients for whom Aptivus treatment is initiated by their physician * Aptivus SCP respect
Exclusion criteria
None if the inclusion criteria are respected: observational study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3 | 6 months after inclusion | The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Viral Load Response at 1 Month | 1 month after inclusion | Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL. |
| CD4 Count at 1 Month | 1 month after inclusion | — |
| Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL | 3 months after inclusion | Number of patients with a viral load \< 400 copies/mL after 3 months of treatment |
| Evaluation of Early Virological Response | 1 month after inclusion | Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10 |
| Viral Load Response at 3 Months | 3 months after inclusion | Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL. |
| CD4 Count at 3 Months | 3 months after inclusion | — |
| Patient Self Perception of the New Treatment | Day 0, month 3 and month 6 | Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied |
| Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL | 3 months after inclusion | Number of patients with a viral load \< 50 copies/mL after 3 months of treatment |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aptivus Patients treated by Aptivus in daily practice | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Aptivus |
|---|---|
| Age, Continuous | 43.9 Years STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 42 |
| serious Total, serious adverse events | 3 / 42 |
Outcome results
Primary
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3
The evaluation at month 6 of an immunovirological response defined by a viral load less than 50 copies/mL and a gain in CD4 between day 0 and month 6 higher than 100 cells/mm3
Time frame: 6 months after inclusion
Population: All enrolled patients with data at 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aptivus | Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3 | 8 participants |
Secondary
CD4 Count at 1 Month
Time frame: 1 month after inclusion
Population: All enrolled patients with data at 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aptivus | CD4 Count at 1 Month | 349.0 cells/cubic millimeter |
Secondary
CD4 Count at 3 Months
Time frame: 3 months after inclusion
Population: All enrolled patients with data at 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aptivus | CD4 Count at 3 Months | 322.5 cells/cubic millimeter |
Secondary
Evaluation of Early Virological Response
Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10
Time frame: 1 month after inclusion
Population: All enrolled patients with data at 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aptivus | Evaluation of Early Virological Response | 20 participants |
Secondary
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL
Number of patients with a viral load \< 400 copies/mL after 3 months of treatment
Time frame: 3 months after inclusion
Population: All enrolled patients with data at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aptivus | Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL | 28 participants |
Secondary
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL
Number of patients with a viral load \< 50 copies/mL after 3 months of treatment
Time frame: 3 months after inclusion
Population: All enrolled patients with data at 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aptivus | Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL | 24 participants |
Secondary
Patient Self Perception of the New Treatment
Visual analogue scale range from 0 not at all satisfied to 100 extremely satisfied
Time frame: Day 0, month 3 and month 6
Population: All enrolled patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Aptivus | Patient Self Perception of the New Treatment | Day 0 (n=28) | 59 millimeter | Standard Deviation 25 |
| Aptivus | Patient Self Perception of the New Treatment | Month 3 (n=28) | 76 millimeter | Standard Deviation 24 |
| Aptivus | Patient Self Perception of the New Treatment | Month 6 (n=23) | 74 millimeter | Standard Deviation 25 |
Secondary
Viral Load Response at 1 Month
Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL.
Time frame: 1 month after inclusion
Population: All enrolled patients with data at 1 month
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aptivus | Viral Load Response at 1 Month | 71.5 copies/mL |
Secondary
Viral Load Response at 3 Months
Please note that a reported value of 49 copies/mL for the median or first quartile indicates that the observed statistic for the outcome measure is below the limit of quantification for viral load. The limit of quantification is 50 copies/mL.
Time frame: 3 months after inclusion
Population: All enrolled patients with data at 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Aptivus | Viral Load Response at 3 Months | 49 copies/mL |