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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

Brief Summary:
The levels of lopinavir achieved in the blood following oral ingestion of standard doses of Kaletra (lopinavir/ritonavir) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the drug.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: LPV/r Phase 4

Detailed Description:

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 twice daily to 800/200 mg once daily dosing. Tolerability (measured by toxicity grade of diarrhea) and change in quality of life following switch from twice daily to once daily dosing will also be assessed using appropriate validated measurement tools.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Switch From Twice Daily to Once Daily Lopinavir/Ritonavir: A 24-hour Pharmacokinetic Profile to Evaluate Sex Differences
Study Start Date : June 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Lopinavir

Arm Intervention/treatment
Active Comparator: adult male subjects
LPV/r 800/200 mg once daily
Drug: LPV/r
LPV/r 800/200 mg once daily
Other Names:
  • Daily LPV/r
  • Kaletra

Experimental: Adult female subjects
LPV/r 800/200 mg once daily
Drug: LPV/r
LPV/r 800/200 mg once daily
Other Names:
  • Daily LPV/r
  • Kaletra

Primary Outcome Measures :
  1. 24-hr LPV AUC [ Time Frame: 24 hours ]
    Steady state(2 weeks after therapy change)

Secondary Outcome Measures :
  1. 24-hr LPV Cmax [ Time Frame: 24 hours ]
    LPV Cmax at Steady State

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater or equal to 18 years
  • Diagnosis of HIV infection as previously established by HIV Enzyme-Linked Immunosorbent Assay (ELISA) test and confirmed by Western blot analysis.
  • Must have been taking LPV/r as part of an antiretroviral regimen at a dose of 400/100 mg orally twice per day for at least 3 months.
  • Recent (within last 90 days) HIV-RNA copies must be less than 400 copies/ml

Exclusion Criteria:

  • Hepatic abnormality: alanine-aminotransferase (ALT), aspartate-aminotransferase (AST) or total bilirubin (TBR) ≥ 3 x upper limit of normal
  • Renal insufficiency: serum creatinine ≥ 2 mg/dl
  • Co-infection with hepatitis B and/or C viruses
  • Pregnant or breastfeeding
  • Use of concurrent medications known to affect lopinavir or ritonavir concentrations significantly.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148759

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United States, Georgia
Grady Infectious Diseases Program
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
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Principal Investigator: Igho Ofotokun, MD, MSc Emory University

Publications of Results:
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Responsible Party: Ighovwerha Ofotokun, Associate Professor of Medicine, 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 Posted: September 8, 2005    Key Record Dates
Results First Posted: October 22, 2013
Last Update Posted: December 3, 2013
Last Verified: November 2013
Keywords provided by Ighovwerha Ofotokun, Emory University:
Sex differences
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors