HIV Infections Clinical Trial
Official title:
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) in HIV-infected men was compared with those achieved in HIV-infected women receiving the same dose of the 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 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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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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