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Kaletra Sex/Gender Pharmacokinetics (PK) Study (LPVGenderPK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148759
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 22, 2013
Last Update Posted : December 3, 2013
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: LPV/r

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
Male Arm Male subjects
Female Arm Female subjects

Participant Flow:   Overall Study
    Male Arm   Female Arm
STARTED   11   12 
24-hr PK Sampling   9   11 
COMPLETED   9   11 
Withdrawal by Subject                1                1 
Lost to Follow-up                1                0 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Group 1 Male subjects
Group 2 Female subjects
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   12   23 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   11   12   23 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 37  (16)   39  (18)   38  (16) 
[Units: Participants]
Female   0   12   12 
Male   11   0   11 
Region of Enrollment 
[Units: Participants]
United States   11   12   23 

  Outcome Measures

1.  Primary:   24-hr LPV AUC   [ Time Frame: 24 hours ]

2.  Secondary:   24-hr LPV Cmax   [ Time Frame: 24 hours ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Ighovwerha Ofotokun, MD, MSc
Organization: Emory University
phone: 404-616-0659

Publications of Results:

Responsible Party: Ighovwerha Ofotokun, Emory University Identifier: NCT00148759     History of Changes
Other Study ID Numbers: IRB00002448
UPN 04092824 ( Other Grant/Funding Number: Abbott Virology )
GCRC0605G ( Other Identifier: Other )
First Submitted: September 6, 2005
First Posted: September 8, 2005
Results First Submitted: November 24, 2009
Results First Posted: October 22, 2013
Last Update Posted: December 3, 2013