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Trial Outcomes & Findings for Kaletra Sex/Gender Pharmacokinetics (PK) Study (NCT NCT00148759)

NCT ID: NCT00148759

Last Updated: 2013-12-03

Results Overview

Steady state(2 weeks after therapy change)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

24 hours

Results posted on

2013-12-03

Participant Flow

Subjects were recruited from the Grady Infectious Diseases Clinic in Atlanta, Georgia between June 2005 and January 2007. All subjects provided written informed consent before undergoing any study procedures.

Of the 23 subjects enrolled, 20 completed the study including the PK sampling. Three subjects (2 males and 1 female) dropped out. Two subjects were unavailable for the 24-hour PK sampling because of changes in their work schedules, and the third subject was lost to follow-up after the initial study visit.

Participant milestones

Participant milestones
Measure
Male Arm
Male subjects
Female Arm
Female subjects
Overall Study
STARTED
11
12
Overall Study
24-hr PK Sampling
9
11
Overall Study
COMPLETED
9
11
Overall Study
NOT COMPLETED
2
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Male Arm
Male subjects
Female Arm
Female subjects
Overall Study
Withdrawal by Subject
1
1
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

Kaletra Sex/Gender Pharmacokinetics (PK) Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Group 1
n=11 Participants
Male subjects
Group 2
n=12 Participants
Female subjects
Total
n=23 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
11 Participants
n=5 Participants
12 Participants
n=7 Participants
23 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age Continuous
37 years
STANDARD_DEVIATION 16 • n=5 Participants
39 years
STANDARD_DEVIATION 18 • n=7 Participants
38 years
STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
12 Participants
n=7 Participants
12 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
0 Participants
n=7 Participants
11 Participants
n=5 Participants
Region of Enrollment
United States
11 participants
n=5 Participants
12 participants
n=7 Participants
23 participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Steady state(2 weeks after therapy change)

Outcome measures

Outcome measures
Measure
Group 1
n=9 Participants
Male subjects
Group 2
n=11 Participants
Female subjects
24-hr LPV AUC
142,160 ng*hr/mL
Interval 136300.0 to 191390.0
152140 ng*hr/mL
Interval 110840.0 to 214180.0

SECONDARY outcome

Timeframe: 24 hours

LPV Cmax at Steady State

Outcome measures

Outcome measures
Measure
Group 1
n=9 Participants
Male subjects
Group 2
n=11 Participants
Female subjects
24-hr LPV Cmax
12417 ng/mL
Interval 11622.0 to 13699.0
12271 ng/mL
Interval 7219.0 to 14113.0

Adverse Events

Group 1

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group 2

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ighovwerha Ofotokun, MD, MSc

Emory University

Phone: 404-616-0659

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place