Kaletra Sex/Gender Pharmacokinetics (PK) Study (LPVGenderPK)
HIV Infections
About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Sex differences, Pharmacokinetic, Lopinavir/ritonavir, Treatment Experienced, HIV-infection
Eligibility Criteria
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.
Sites / Locations
- Grady Infectious Diseases Program
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
adult male subjects
Adult female subjects
LPV/r 800/200 mg once daily
LPV/r 800/200 mg once daily