Kaletra Sex/Gender Pharmacokinetics (PK) Study

Phase 4 Completed 23 enrolled Emory University Abbott · collab

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-06
Primary completion: 2007-01
Completion: 2007-01

Publications

Results Ofotokun I, Chuck SK, Binongo JN, Palau M, Lennox JL, Acosta EP. Lopinavir/Ritonavir pharmacokinetic profile: impact of sex and other covariates following a change from twice-daily to once-daily therapy. J Clin Pharmacol. 2007 Aug;47(8):970-7. doi: 10.1177/0091270007302564. Epub 2007 Jul 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LPV/r	Unknown	200 mg	Oral
Subject	LPV/r	Unknown	800 mg	Oral
Subject	Lopinavir	Other / unclassified	800 mg	Oral
Subject	Ritonavir	Other / unclassified	200 mg	Oral

Kaletra Sex/Gender Pharmacokinetics (PK) Study

Summary

Timeline

Publications

Drugs

Indications