HIV Infections Clinical Trial
Official title:
Sex Differences in Lopinavir/Ritonavir Pharmacokinetics Among HIV-1-Infected Men and Women
Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.
It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected
women face different psychosocial issues than men, and their bodies may react differently to
HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals
(ARVs) used in the treatment of HIV infection are from studies conducted primarily in men.
LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the
differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet
formulation of LPV/r.
No ARVs will be provided by this study. In Step 1, participants will receive soft gel
capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon
completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the
study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily
and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI),
tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood
collection, and clinical assessments will occur at study screening for both Steps 1 and 2.
Participants in both steps will be asked to complete a medication diary from study entry to
the day of the PK visit. The PK visit will occur within 30 days of study screening; blood
collection for PK analysis will also occur at this visit.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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