HIV Infections
Conditions
Brief summary
The aim of this trial is to evaluate the safety and virological and immunological efficacy of Aptivus in treatment-experienced patients with advanced HIV-1 infection who had developed resistance to more than one protease inhibitor.
Interventions
DRUGTipranavir
DRUGritonavir
low-dose
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
1. HIV-1 infected patients who are treatment experienced and infected with HIV-1 strains resistant to more than one protease inhibitor and no other therapeutic options. 2. The inclusion criteria follow the same criteria which are describe in the newest SPC
Exclusion criteria
The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Reporting Adverse Events (AE) | 48 weeks | Any type of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Virologic Response | 48 weeks | Virologic response is defined as HIV viral load of \< 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL \>= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients. |
| Change in CD4+ Cell Count From Baseline at Week 48 | 48 weeks | — |
Countries
Romania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Events with no relationship to Aptivus | 3 |
Baseline characteristics
| Characteristic | Aptivus and Ritonavir |
|---|---|
| Age, Continuous | 25.5 years STANDARD_DEVIATION 10.4 |
| Baseline CD4+ count 251 - <451 cells/mm^3 | 13 Participants |
| Baseline CD4+ count >= 451 cells/mm^3 | 8 Participants |
| Baseline CD4+ count <= 50 cells/mm^3 | 2 Participants |
| Baseline CD4+ count 51 - <251 cells/mm^3 | 19 Participants |
| Baseline HIV RNA values >= 1,000,000 copies/ml | 0 Participants |
| Baseline HIV RNA values 100,000 - <1,000,000 copies/ml | 12 Participants |
| Baseline HIV RNA values 10,000 - <100,000 copies/ml | 13 Participants |
| Baseline HIV RNA values 1,000 - <10,000 copies/ml | 5 Participants |
| Baseline HIV RNA values <= 50 copies/ml | 0 Participants |
| Baseline HIV RNA values 51 - <1,000 copies/ml | 1 Participants |
| Baseline HIV RNA values Missing | 11 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 23 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 | 1 / 42 |
Outcome results
Primary
Number of Patients Reporting Adverse Events (AE)
Any type of adverse events
Time frame: 48 weeks
Population: Treated set (TS), defined as patients treated with Aptivus
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aptivus and Ritonavir | Number of Patients Reporting Adverse Events (AE) | Patients with any adverse events | 6 Participants |
| Aptivus and Ritonavir | Number of Patients Reporting Adverse Events (AE) | Patients with any serious adverse events | 1 Participants |
| Aptivus and Ritonavir | Number of Patients Reporting Adverse Events (AE) | Patients with AE leading to discontinuation | 4 Participants |
| Aptivus and Ritonavir | Number of Patients Reporting Adverse Events (AE) | Patients with hepatic adverse events | 1 Participants |
| Aptivus and Ritonavir | Number of Patients Reporting Adverse Events (AE) | Patients with dyslipidemia | 2 Participants |
Secondary
Change in CD4+ Cell Count From Baseline at Week 48
Time frame: 48 weeks
Population: Treated set with with non-missing data at the visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Aptivus and Ritonavir | Change in CD4+ Cell Count From Baseline at Week 48 | 85.8 cells/mm^3 | Standard Deviation 29.6 |
Secondary
Virologic Response
Virologic response is defined as HIV viral load of \< 50 copies/mL before week 48 and without subsequent rebound or change of ARV therapy prior to week 48. A rebound is defined by two consecutive measurements of VL \>= 50 copies/ml, at least two weeks apart, after two consecutive measurements of VL\< 50 copies/ml. Because of many missing data concerning the viral load, the virologic response could be determined only for four patients.
Time frame: 48 weeks
Population: Treated set (TS), defined as patients treated with Aptivus
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aptivus and Ritonavir | Virologic Response | Virologic response - Yes | 0 Number of participants |
| Aptivus and Ritonavir | Virologic Response | Virologic response - No | 4 Number of participants |
| Aptivus and Ritonavir | Virologic Response | Virologic response - Missing | 38 Number of participants |