Kaletra Sex/Gender Pharmacokinetics (PK) Study

Completed · Phase 4

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00148759

Run by

Emory University

People needed

23

Starts

2005-06-01

Expected to finish

2007-01-01

Last updated by the study team

2013-12-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Grady Infectious Diseases Program — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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