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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier:
NCT00148759
First received: September 6, 2005
Last updated: November 8, 2013
Last verified: November 2013
Results First Received: November 24, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV Infections
Intervention: Drug: LPV/r

  Participant Flow
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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
  Description
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  
NOT COMPLETED     2     1  
Withdrawal by Subject                 1                 1  
Lost to Follow-up                 1                 0  



  Baseline Characteristics
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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
  Description
Group 1 Male subjects
Group 2 Female subjects
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  11     12     23  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     12     23  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  37  ± 16     39  ± 18     38  ± 16  
Gender  
[units: participants]
     
Female     0     12     12  
Male     11     0     11  
Region of Enrollment  
[units: participants]
     
United States     11     12     23  



  Outcome Measures
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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


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


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.  


Results Point of Contact:  
Name/Title: Ighovwerha Ofotokun, MD, MSc
Organization: Emory University
phone: 404-616-0659
e-mail: iofotok@emory.edu


Publications of Results:

Responsible Party: Ighovwerha Ofotokun, Emory University
ClinicalTrials.gov Identifier: NCT00148759     History of Changes
Other Study ID Numbers: IRB00002448, UPN 04092824, GCRC0605G
Study First Received: September 6, 2005
Results First Received: November 24, 2009
Last Updated: November 8, 2013
Health Authority: United States: Institutional Review Board