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Kaletra (Lopinavir / Ritonavir) - Summary

 



KALETRA SUMMARY

KALETRA®
(lopinavir/ritonavir) capsules
(lopinavir/ritonavir) oral solution

KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV protease. As co-formulated in KALETRA, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.

KALETRA is indicated in combination with other antiretroviral agents for the treatment of HIV-infection.
See all indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Kaletra (Lopinavir / Ritonavir)

lopinavir and ritonavir, Kaletra
Source: MedicineNet atazanavir Specialty [2005.10.16]
Title: lopinavir and ritonavir, Kaletra
Category: Medications
Created: 3/12/2001 10:51:00 PM
Last Editorial Review: 10/16/2005

Perinatal HIV Infection Highest Among Blacks
Source: MedPage Today Infectious Disease [2010.02.04]
The rate of mother-to-child HIV transmission among infants is 23 times higher for blacks than whites, the CDC reported.

Clinical Trial Proves New Vaccine Effective In Preventing TB In African Patients With HIV Infection
Source: HIV / AIDS News From Medical News Today [2010.02.01]
Investigators from Dartmouth Medical School (DMS) have reported results of a clinical trial showing that a new vaccine against tuberculosis, Mycobacterium vaccae (MV), is effective in preventing tuberculosis in people with HIV infection...

Drug Combo Blocks HIV Infection in Mice
Source: MedicineNet Human Immunodeficiency Virus (HIV, AIDS) Specialty [2010.01.25]
Title: Drug Combo Blocks HIV Infection in Mice
Category: Health News
Created: 1/22/2010 12:10:00 PM
Last Editorial Review: 1/25/2010

Black and Hispanic Infants Much More Likely to Have HIV (HealthDay)
Source: Y! Health HIV & AIDS News [2010.02.04]
HealthDay - THURSDAY, Feb. 4 (HealthDay News) -- Rates of HIV infection in infants are significantly higher among blacks and Hispanics than whites, and preventive measures are needed to reduce the disparity, a new government report says.

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Published Studies Related to Kaletra (Lopinavir / Ritonavir)

Randomized, double-blind, placebo-matched, multicenter trial of abacavir/lamivudine or tenofovir/emtricitabine with lopinavir/ritonavir for initial HIV treatment. [2009.07.31]
BACKGROUND: Abacavir sulfate/lamivudine (ABC/3TC) and tenofovir DF/emtricitabine (TDF/FTC) are widely used nucleoside reverse transcriptase inhibitors for initial HIV-1 treatment. This is the first completed, randomized clinical trial to directly compare the efficacy, safety, and tolerability of these agents, each in combination with lopinavir/ritonavir in antiretroviral-naive patients... CONCLUSION: Both ABC/3TC and TDF/FTC provided comparable antiviral efficacy, safety, and tolerability when each was combined with lopinavir/ritonavir in treatment-naive patients.

Protease inhibitor resistance analysis in the MONARK trial comparing first-line lopinavir-ritonavir monotherapy to lopinavir-ritonavir plus zidovudine and lamivudine triple therapy. [2009.07]
The MONARK study was a pilot randomized trial comparing the safety and efficacy of lopinavir-ritonavir (LPV/r) monotherapy to those of LPV/r-zidovudine-lamivudine triple therapy for antiretroviral-naive human immunodeficiency virus type 1 (HIV-1)-infected patients...

Lopinavir-ritonavir monotherapy versus lopinavir-ritonavir and 2 nucleosides for maintenance therapy of HIV: 96-week analysis. [2009.06.01]
BACKGROUND: The OK04 trial has shown that 48 weeks of lopinavir-ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy with 2 nucleosides and lopinavir-ritonavir in patients with prior stable suppression. However, it is still uncertain if this experimental strategy can maintain suppression in the long term... CONCLUSIONS: At 96-week lopinavir/ritonavir monotherapy with reintroduction of nucleosides as needed was noninferior to continuation of triple therapy. Incidence of adverse events leading to treatment discontinuation was significantly lower with monotherapy. (ClinicalTrials.gov number, NCT00114933).

Efficacy and safety of switching from boosted lopinavir to boosted atazanavir in patients with virological suppression receiving a LPV/r-containing HAART: the ATAZIP study. [2009.05.01]
OBJECTIVES: To evaluate the efficacy and safety of switching from boosted lopinavir (LPV/r) to boosted atazanavir (ATV/r) in virologically suppressed HIV-1-infected patients versus continuing LPV/r... CONCLUSIONS: Switching to ATV/r in virologically suppressed patients who were receiving a LPV/r-containing highly active antiretroviral therapy provided comparable (noninferior) efficacy and a safety profile with improved lipid parameters [ISRCTN24813210].

Application of a rapid and selective method for the simultaneous determination of protease inhibitors, lopinavir and ritonavir in human plasma by UPLC-ESI-MS/MS for bioequivalence study in Indian subjects. [2009.05.01]
A high throughput and rugged ultra performance liquid chromatography tandem mass spectrometry (UPLC-ESI-MS/MS) method is developed and validated for the selective determination of protease inhibitors -- lopinavir (LPV) and ritonavir (RTV) in human plasma... The method was successfully applied to a bioequivalence study of [200(lopinavir)+50(ritonavir)]mg tablet formulation in 36 healthy human subjects under fasting conditions.

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Clinical Trials Related to Kaletra (Lopinavir / Ritonavir)

A Comparison Study of Kaletra Soft-Gel Capsules and Kaletra Tablets in an African American Cohort [Completed]
The purpose of this study is to compare Kaletra tablets with Kaletra soft-gel capsules to see if there is any change in the side effects you may have and to see how people in the study feel about using the tablets.

Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients [Completed]

A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules [Not yet recruiting]
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 once daily therapy. While lopinavir/ritonavir has recently been approved as a once daily therapy it was associated with considerable diarrhea in those treated with soft gel capsules. It is the hope that alternative formulations of lopinavir/ritonavir may provide similar pharmacokinetics with improved tolerability. This includes the possibility of using liquid or newly released tablets. This study will treat people tolerating their current regimen with up to four weeks of each formulation with several assessments of pharmacokinetics and tolerability for each.

Safety and Efficacy of Kaletra in ARV Therapy Experienced Patients [Terminated]
To demonstrate that patients treated with Kaletra have an improvement in their quality of life compared to the quality of life they had with their previous NRTI therapy.

Lopinavir/Ritonavir Monotherapy vs Standard HAART in HIV/HCV Coinfected ARV Naive Patients Starting Treatment With Anti HCV Therapy [Recruiting]
The purpose of this study is to evaluate if the combination of Lpv/r monotherapy and anti-HCV drugs does not match with additional toxicity induced by the association of HAART and Peg-IFN + ritonavir in patients naive for HIV and HCV.

Secondary objective is to assess if Lpv/r monotherapy during HCV-treatment is associated with HIV efficacy vs optimized HAART.

more trials >>

Page last updated: 2010-02-04

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