Trial Outcomes & Findings for A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice. (NCT NCT00976950)

NCT ID: NCT00976950

Last Updated: 2014-03-20

Results Overview

Any type of adverse events

• Recruitment status: COMPLETED
• Target enrollment: 42 participants
• Primary outcome timeframe: 48 weeks
• Results posted on: 2014-03-20

Participant Flow

Participant milestones

Measure	Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Study STARTED	42
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Aptivus and Ritonavir TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Overall Study Adverse Event	3
Overall Study Events with no relationship to Aptivus	3

Baseline Characteristics

A Post Marketing Surveillance Study Assessing the Long-term Efficacy and Safety of Aptivus Co-administered With Low-dose Ritonavir in Treatment Experienced Patients With HIV-1 Infection in the Daily Clinical Practice.

Baseline characteristics by cohort

Measure	Aptivus and Ritonavir n=42 Participants TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Age, Continuous	25.5 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Baseline HIV RNA values <= 50 copies/ml	0 Participants n=5 Participants
Baseline HIV RNA values 51 - <1,000 copies/ml	1 Participants n=5 Participants
Baseline HIV RNA values 1,000 - <10,000 copies/ml	5 Participants n=5 Participants
Baseline HIV RNA values 10,000 - <100,000 copies/ml	13 Participants n=5 Participants
Baseline HIV RNA values 100,000 - <1,000,000 copies/ml	12 Participants n=5 Participants
Baseline HIV RNA values >= 1,000,000 copies/ml	0 Participants n=5 Participants
Baseline HIV RNA values Missing	11 Participants n=5 Participants
Baseline CD4+ count <= 50 cells/mm^3	2 Participants n=5 Participants
Baseline CD4+ count 51 - <251 cells/mm^3	19 Participants n=5 Participants
Baseline CD4+ count 251 - <451 cells/mm^3	13 Participants n=5 Participants
Baseline CD4+ count >= 451 cells/mm^3	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Treated set (TS), defined as patients treated with Aptivus

Any type of adverse events

Outcome measures

Measure	Aptivus and Ritonavir n=42 Participants TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Number of Patients Reporting Adverse Events (AE) Patients with any adverse events	6 Participants
Number of Patients Reporting Adverse Events (AE) Patients with any serious adverse events	1 Participants
Number of Patients Reporting Adverse Events (AE) Patients with AE leading to discontinuation	4 Participants
Number of Patients Reporting Adverse Events (AE) Patients with hepatic adverse events	1 Participants
Number of Patients Reporting Adverse Events (AE) Patients with dyslipidemia	2 Participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Treated set (TS), defined as patients treated with Aptivus

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.

Outcome measures

Measure	Aptivus and Ritonavir n=42 Participants TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Virologic Response Virologic response - Yes	0 Number of participants
Virologic Response Virologic response - No	4 Number of participants
Virologic Response Virologic response - Missing	38 Number of participants

SECONDARY outcome

Timeframe: 48 weeks

Population: Treated set with with non-missing data at the visit

Outcome measures

Measure	Aptivus and Ritonavir n=28 Participants TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Change in CD4+ Cell Count From Baseline at Week 48	85.8 cells/mm^3 Standard Deviation 29.6

Adverse Events

Aptivus and Ritonavir

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aptivus and Ritonavir n=42 participants at risk ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
Infections and infestations Pulmonary tuberculosis	2.4% 1/42

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER