Trial Outcomes & Findings for Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy (NCT NCT00615290)

NCT ID: NCT00615290

Last Updated: 2014-08-08

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 42 participants
• Primary outcome timeframe: 6 months after inclusion
• Results posted on: 2014-08-08

Participant Flow

Participant milestones

Measure	Aptivus Patients treated by Aptivus in daily practice
Overall Study STARTED	42
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Aptivus Patients treated by Aptivus in daily practice
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	1
Overall Study Other	2

Baseline Characteristics

Pharmaco-epidemiological Description of the Population Treated With Aptivus Under Market Conditions, Safety & Efficacy

Baseline characteristics by cohort

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Age, Continuous	43.9 Years STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after inclusion

Population: All enrolled patients with data at 6 months

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

Outcome measures

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Number of Patients With a Viral Load< 50 Copies/mL and a Gain in CD4 Higher Than 100 Cells/mm3	8 participants

SECONDARY outcome

Timeframe: 1 month after inclusion

Population: All enrolled patients with data at 1 month

Number of patients presenting a decrease of viral load (HIV-RNA copies per mL) from day 0 to month 1 higher than 1 log10

Outcome measures

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Evaluation of Early Virological Response	20 participants

SECONDARY outcome

Timeframe: 1 month after inclusion

Population: All enrolled patients with data 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.

Outcome measures

Measure	Aptivus n=34 Participants Patients treated by Aptivus in daily practice
Viral Load Response at 1 Month	71.5 copies/mL Interval 49.0 to 500.0

SECONDARY outcome

Timeframe: 1 month after inclusion

Population: All enrolled patients with data at 1 month

Outcome measures

Measure	Aptivus n=35 Participants Patients treated by Aptivus in daily practice
CD4 Count at 1 Month	349.0 cells/cubic millimeter Interval 198.0 to 514.0

SECONDARY outcome

Timeframe: 3 months after inclusion

Population: All enrolled patients with data at 3 months

Number of patients with a viral load < 400 copies/mL after 3 months of treatment

Outcome measures

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Evaluation of Intermediate Virological Response, Viral Load < 400 Copies/mL	28 participants

SECONDARY outcome

Timeframe: 3 months after inclusion

Population: All enrolled patients with data at 3 months

Number of patients with a viral load < 50 copies/mL after 3 months of treatment

Outcome measures

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Evaluation of Intermediate Virological Response, Viral Load < 50 Copies/mL	24 participants

SECONDARY outcome

Timeframe: 3 months after inclusion

Population: All enrolled patients with data 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.

Outcome measures

Measure	Aptivus n=33 Participants Patients treated by Aptivus in daily practice
Viral Load Response at 3 Months	49 copies/mL Interval 49.0 to 118.0

SECONDARY outcome

Timeframe: 3 months after inclusion

Population: All enrolled patients with data at 3 months

Outcome measures

Measure	Aptivus n=34 Participants Patients treated by Aptivus in daily practice
CD4 Count at 3 Months	322.5 cells/cubic millimeter Interval 240.0 to 520.0

SECONDARY outcome

Timeframe: Day 0, month 3 and month 6

Population: All enrolled patients

Visual analogue scale range from 0 "not at all satisfied" to 100 "extremely satisfied"

Outcome measures

Measure	Aptivus n=42 Participants Patients treated by Aptivus in daily practice
Patient Self Perception of the New Treatment Day 0 (n=28)	59 millimeter Standard Deviation 25
Patient Self Perception of the New Treatment Month 3 (n=28)	76 millimeter Standard Deviation 24
Patient Self Perception of the New Treatment Month 6 (n=23)	74 millimeter Standard Deviation 25

Adverse Events

Aptivus

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aptivus n=42 participants at risk Patients treated by Aptivus in daily practice
Hepatobiliary disorders Cytolitic hepatitis	4.8% 2/42
Hepatobiliary disorders Hepatitis	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