Kaletra Sex/Gender Pharmacokinetics (PK) Study

• Status: Completed
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: Abbott
• Treatments: Lopinavir; Ritonavir

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.