Kaletra Sex/Gender Pharmacokinetics (PK) Study: A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir
Recruitment status was Recruiting
|First Received Date ICMJE||September 6, 2005|
|Last Updated Date||February 9, 2006|
|Start Date ICMJE||June 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||To compare the 24-hour pharmacokinetic profile of lopinavir (LPV) following a switch from LPV/ritonavir (r) twice daily (BID) to once daily (QD) dosing among HIV-infected men and women|
|Original Primary Outcome Measures ICMJE
||To compare the 24-hour pharmacokinetic profile of LPV following a switch from LPV/r BID to QD dosing among HIV-infected men and women|
|Change History||Complete list of historical versions of study NCT00148759 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Kaletra Sex/Gender Pharmacokinetics (PK) Study: A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir|
|Official Title ICMJE||A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir: A 24-Hour Pharmacokinetic Profile to Evaluate Sex Differences|
The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) is the same among HIV-infected men compared with HIV-infected women being treated with this drug.
The association between patient sex and the tolerability of antiretroviral drugs (ARVs) is increasingly being recognized. Several lines of evidence suggest that women are more likely than men to develop side effects to ARVs. On the other hand, it has been generally accepted that the efficacies of the ARVs are similar in both sexes. However, recent studies suggest that this may not always be the case. In addition to these observed sex-related differences in the effects of ARVs, there is growing evidence that the pharmacokinetic profile of some of these drugs may be different among male and female HIV infected patients.
The fact that female sex is a risk factor for enhanced antiretroviral effects (including toxicities) has an important implication, particularly from a global health perspective as women now represent the fastest growing segment of the HIV/AIDS epidemic. Therefore, an understanding of the magnitude, clinical significance, and the mechanisms underlying this phenomenon deserves further study. Knowledge acquired from such studies will likely contribute to improved survival among female HIV-infected patients, through optimization of antiretroviral therapeutic regimens in manners that minimize serious adverse effects and improve adherence.
Similarly, the influence of race on the pharmacological effects of ARVs deserves further investigation. Although, there is no reason to believe based on available evidence that racial differences exist in the pharmacological effects of ARVs, the need however exists to explore the influence of race on ARVs pharmacokinetics and treatment outcomes. This is so because data on race related differences on ARV effects is limited, and in addition, people of ethnic minority have been disproportionately under represented in clinical trials involving these drugs in spite of the fact that they bear a larger burden of the HIV epidemic.
Our study will examine the influence of race and sex on the 24-hr pharmacokinetics of lopinavir/ritonavir (an antiretroviral agent commonly used in naïve patients) following a switch from LPV/r 400/100 mg BID to 800/200 mg QD dosing. Tolerability (measured by toxicity grade of diarrhea) and change in quality of life following switch from BID to QD dosing will also be assessed using appropriate validated measurement tools.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
|Condition ICMJE||HIV Infections|
|Intervention ICMJE||Drug: Kaletra|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00148759|
|Other Study ID Numbers ICMJE||GCRC0605G, UPN 04092824|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Emory University|
|Information Provided By||Emory University|
|Verification Date||September 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP