Track topics on Twitter Track topics that are important to you
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
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.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
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
Enrolling by invitation
The National Centre in HIV Epidemiology and Clinical Research
Published on BioPortfolio: 2014-08-27T03:19:00-0400
The objective of this study is to compare the pharmacokinetics of lopinavir tablets administered to pediatric patients as either whole or crushed tablets. The study is a randomized,open-la...
Guidelines have continued to list lopinavir/ritonavir as a preferred protease inhibitor-containing regimen for HIV-infected individuals. There has recently been increasing interest in onc...
The purpose of this study is to compare the safety, tolerability and antiviral activity between once-daily (QD) and twice-daily (BID) dosing of lopinavir/ritonavir and to further character...
The purpose of this study is to compare the safety, tolerability and antiviral activity of the lopinavir/ritonavir tablet when administered in combination with reverse transcriptase inhibi...
To determine the pharmacokinetic profile of generic lopinavir/ritonavir tablets To investigate the possible influence of pregnancy and duration of pregnancy To determine the antiviral acti...
To estimate the long-term metabolic effects of initiating a lopinavir/ritonavir (LPV/r)-based regimen as first-line therapy for HIV-infected children less than three years of age in resource-limited s...
In a previous trial of antiretroviral therapy (ART) involving pregnant women with human immunodeficiency virus (HIV) infection, those randomly assigned to receive tenofovir, emtricitabine, and ritonav...
Nowadays, zidovudine, efavirenz, lopinavir and ritonavir are important components of the second-line antiretroviral therapeutic regimen of National Free Antiretroviral Treatment Program in China. The ...
The QoLKAMON study evaluated quality of life, efficacy and treatment safety in HIV patients receiving lopinavir/ritonavir in monotherapy (MT) versus continuing combined antiretroviral triple treatment...
The goal of this study is to profile the metabolic changes in the plasma of HIV patients receiving lopinavir/ritonavir (LPV/r)-based highly active antiretroviral therapy (HAART) relative to their trea...
An HIV protease inhibitor used in a fixed-dose combination with RITONAVIR. It is also an inhibitor of CYTOCHROME P-450 CYP3A.
Tablets coated with material that delays release of the medication until after they leave the stomach. (Dorland, 28th ed)
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.
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.
Heat and cold stress-inducible, transcription factors that bind to inverted 5'-NGAAN-3' pentamer DNA sequences and are regulated by poly(ADP) ribosylation. They play essential roles as transcriptional activators of the HEAT-SHOCK RESPONSE by inducing expression of large classes of MOLECULAR CHAPERONES and heat-shock proteins. They also function in DNA REPAIR; transcriptional reactivation of latent HIV-1; and pre-mRNA processing and nuclear export of HSP70 HEAT-SHOCK PROTEINS during heat stress.
Antiretroviral Therapy Clostridium Difficile Ebola HIV & AIDS Infectious Diseases Influenza Malaria Measles Sepsis Swine Flu Tropical Medicine Tuberculosis Infectious diseases are caused by pathogenic...
Standard antiretroviral therapy (ART) consists of the combination of at least three antiretroviral (ARV) drugs to maximally suppress the HIV virus and stop the progression of HIV disease. Huge reductions have been seen in rates of death and suffering whe...