Pharmacokinetics of Lopinavir/Ritonavir at Three Different Doses.
Summary
The successful treatment of HIV infection relies on the use of combinations of antiretroviral therapy (cART) to achieve durable viral suppression and to minimize the emergence of resistant viral strains. Recommended doses for antiretroviral (ARV) drugs are often determined early in clinical development by an innovator company fast−tracking the drug to market. Clinical and pharmacokinetic (PK) (mechanisms of absorption and distribution) evidence indicates that the recommended doses of certain ARVs should be reappraised. This may particularly be true for a class of ARV's boosted protease inhibitors, such as Kaletra (lopinavir/ritonavir).nThe purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over 12 hours dosing interval of following administration to male and female HIV−negative healthy volunteers of:
1. Lopinavir/ritonavir 400/100 mg twice daily
2. Lopinavir/ritonavir 200/150 mg twice daily
3. Lopinavir/ritonavir 200/50 mg twice daily
Description
The purpose of this study is to assess the pharmacokinetics of plasma lopinavir/ritonavir over the 12 hour dosing interval following administration to male and female HIV−negative volunteers of either 400/100mg, 200/150mg, 200/50mg lopinavir/ritonavir twice daily. data during the development of lopinavir/ritonavir shows that lower drug concentration have shown similar efficacy and limited toxicity and cost. Healthy subjects as determined by their medical history and physical examinations will be eligible to participate in the study. The purpose or recruiting healthy and not HIV−positive subjects is that HIV−positive subjects would risk the selection of HIV−resistant mutations, particularly when the volunteers are receiving experimental dose reduced regimen of lopinavir/ritonavir. In addition, there is no reason to presume that there is any meaningful difference in the metabolic processing of lopinavir/ritonavir between HIV−infected and HIV−uninfected people.
Study Design
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Healthy
Intervention
Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets BID), Lopinavir/ritonavir 200/150 mg twice daily, Lopinavir/ritonavir 200/50 mg twice daily
Status
Enrolling by invitation
Source
The National Centre in HIV Epidemiology and Clinical Research
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00985543
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:19:00-0400
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Medical and Biotech [MESH] Definitions
Lopinavir
An HIV protease inhibitor used in a fixed-dose combination with RITONAVIR. It is also an inhibitor of CYTOCHROME P-450 CYP3A.
Tablets, Enteric-coated
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
Enterotoxigenic Escherichia Coli
Strains of ESCHERICHIA COLI that produce or contain at least one member of either heat-labile or heat-stable ENTEROTOXINS. The organisms colonize the mucosal surface of the small intestine and elaborate their enterotoxins causing DIARRHEA. They are mainly associated with tropical and developing countries and affect susceptible travelers to those places.
Antigens, Cd24
A cell adhesion protein that was originally identified as a heat stable antigen in mice. It is involved in METASTASIS and is highly expressed in many NEOPLASMS.
Taq Polymerase
A heat stable DNA-DIRECTED DNA POLYMERASE from the bacteria Thermus aquaticus. It is widely used for the amplification of genes through the process of POLYMERASE CHAIN REACTION. EC 2.7.7.-.
