Media Articles Related to Kaletra (Lopinavir / Ritonavir)
CHMP Backs Generic Lopinavir/Ritonavir Mylan for HIV
Source: Medscape Family Medicine Headlines [2015.11.20]
Studies demonstrate the satisfactory quality of Lopinavir/Ritonavir Mylan and its bioequivalence to the reference product Kaletra, the committee said.
Effect of pre-exposure prophylaxis for HIV infection integrated with community health services
Source: HIV / AIDS News From Medical News Today [2015.11.17]
The rate of acquiring human immunodeficiency virus (HIV) was extremely low despite a high incidence of sexually transmitted infections (STIs) in a study where pre-exposure antiretroviral medication...
IL-21 repairs immune function in primate model of HIV infection
Source: HIV / AIDS News From Medical News Today [2015.11.10]
Restores intestinal immune cells, reduces residual inflammation.Antiretroviral drugs can suppress HIV for years, but a residual inflammatory imbalance contributes to health problems in infected...
Progress toward preventing HIV highlighted in special issue of AIDS research and human retroviruses
Source: HIV / AIDS News From Medical News Today [2015.11.20]
New and emerging biomedical pre-exposure prophylaxis (PrEP) approaches to prevent HIV infection in targeted high-risk populations offer the most effective near-term strategy to reduce HIV...
Published Studies Related to Kaletra (Lopinavir / Ritonavir)
Coadministration with lopinavir and ritonavir decreases exposure to BILR 355, a nonnucleoside reverse transcriptase inhibitor, in healthy volunteers. [2011.07]
The objective of this investigation was to evaluate the pharmacokinetic interaction of lopinavir/ritonavir (LPV/r) with BILR 355. In group A, 26 healthy participants were administered LPV/r (400mg/100mg) twice daily for 14 days, followed by coadministration of BILR 355, 150 mg twice daily for an additional 7 days...
Beneficial effects of a switch to a Lopinavir/ritonavir-containing regimen for patients with partial or no immune reconstitution with highly active antiretroviral therapy despite complete viral suppression. [2011.06]
The purpose of this study was to determine if switching to an Lopinavir/ritonavir (LPV/r)-containing regimen resulted in greater immune reconstitution in patients with immunologic failure despite complete viral suppression with highly active antiretroviral therapy (HAART)... Switching patients to an LPV/r-containing regimen improved CD4(+) counts in patients with prior immunologic failure, and this may be due to an effect of LPV/r on apoptosis.
Comparative gender analysis of the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir at 96 weeks in the CASTLE study. [2011.02]
OBJECTIVES: To examine whether the overall results of the CASTLE study pertain to both genders, we analysed the efficacy and safety of atazanavir/ritonavir and lopinavir/ritonavir in 277 female and 606 male patients in the open-label, multinational trial over 96 weeks. The trial is registered with ClinicalTrials.gov, number NCT00272779... CONCLUSIONS: Once-daily atazanavir/ritonavir is an effective and well-tolerated therapeutic option for women and men with HIV-1 infection. The sex-based differences in response may be due to higher discontinuation rates in women.
The effect of lopinavir/ritonavir and darunavir/ritonavir on the HIV integrase inhibitor S/GSK1349572 in healthy participants. [2011.02]
S/GSK1349572 is an unboosted, once-daily integrase inhibitor with a novel resistance profile. As standard of care for patients infected with HIV is combination therapy, the potential interaction between S/GSK1349572 and ritonavir-boosted protease inhibitors was evaluated... The most frequent drug-related AEs were diarrhea, dizziness, and headache.
Fat tissue distribution changes in HIV-infected patients treated with lopinavir/ritonavir. Results of the MONARK trial. [2011.01.01]
Given the decline in mortality among HIV-infected patients, it has become increasingly important to consider delayed disease-related and/or anti-HIV therapy-related adverse effects, such as lipodystrophy, when choosing initial therapy. Data from the MONARK trial allowed for comparison of the potential lipodystrophic effects of lopinavir/ritonavir (LPV/r) monotherapy with those of triple therapy with LPV/r plus zidovudine (ZDV) and lamivudine (3TC)...
Clinical Trials Related to Kaletra (Lopinavir / Ritonavir)
GSK706769/KALETRA Drug-drug Interaction Study [Completed]
To compare plasma GSK706769 PK following repeat administration of GSK706769 QD with and
without KALETRA (LPV 400 mg/RTV 100mg) q12h
Comparison of Liquid Kaletra and Low Dose Kaletra Tablets [Completed]
Kaletra (a combination drug with lopinavir and ritonavir) is one of a few effective
medications that are approved and available for young children who are HIV+. The liquid
form is reported to have a very nasty taste and presents difficulties for the children who
must take the medication twice a day and for their parents who must enforce the medication
regimen. The children are often well into their teens before they weigh enough to be able
to take the adult dose tablet (200mg/50mg). A new smaller dose tablet (100mg/25mg) is now
available. However, it is not known if the liquid and tablet act the same in children. The
purpose of this study is to switch children from the baseline treatment with the liquid to
the study intervention treatment with 100mg/25mg tablet form of Kaletra. The study will
compare children pre-switch and post-switch in terms of how well their HIV is controlled .
Comparisons of parent and child satisfaction will also be made. Eight to 10 HIV+ children
currently well managed with a medications including liquid Kaletra will be invited to switch
from the liquid to the low dose Kaletra tablet. The parent and/or child will complete a
satisfaction survey for the liquid Kaletra and lab values will be taken from the chart. At
the time of the switch and 1, 3 and 6 months post switch blood tests will be drawn and the
parent and/or child will complete the satisfaction survey. In addition, at the switch and 1
month post switch, a day will be spent in clinic with 5 blood draws to see how much of the
drug is in the blood stream at different times after the medicine is taken.
Lopinavir Capsules to Kaletra or Invirase Tablets [Completed]
This study will compare the benefit for patients switching from KaletraŽ to InviraseŽ
tablets over remaining on KaletraŽ (based on randomization), to elicit the lipid benefits
inferred in previous studies
KONCERT A Kaletra ONCE Daily Randomised Trial of the Pharmacokinetics, Safety and Efficacy of Twice-daily Versus Once-daily Lopinavir/Ritonavir Tablets Dosed by Weight as Part of Combination Antiretroviral Therapy in Human Immunodeficiency Virus-1 (HIV-1) Infected Children (PENTA 18) [Completed]
The trial will evaluate the pharmacokinetics, safety, efficacy and acceptability of twice-
and once-daily dosing of lopinavir/ritonavir tablets (Kaletra) dosed by weight in HIV-1
infected children who are currently taking lopinavir/ritonavir as part of their combination
antiretroviral therapy and who are currently achieving virological suppression (<50
- To confirm weight-based dosing recommendations by evaluating the pharmacokinetics of
twice-daily lopinavir/ritonavir half strength formulation tablets dosed on body weight
and comparing to historical adult and paediatric data of pharmacokinetics of
lopinavir/ritonavir soft gel capsules and oral solution respectively (1, 2).
- To compare the pharmacokinetics of twice-daily lopinavir/ritonavir tablets with
once-daily dosing in the same children.
- To evaluate whether once-daily dosing of lopinavir/ritonavir is comparable to
twice-daily dosing in terms of virological suppression at 48 weeks. Adherence and
acceptability will also be compared.
Drug-drug Interaction Study Between Lopinavir/Ritonavir and Isavuconazole [Completed]
The purpose of this two part study is to assess the effect of multiple doses of
isavuconazole on the pharmacokinetics of multiple doses of lopinavir/ritonavir and the
effect of multiple doses of lopinavir/ritonavir on the pharmacokinetics of isavuconazole.
Part 1 of the study includes 12 subjects randomized to receive either isavuconazole alone or
isavuconazole in combination with lopinavir/ritonavir. The purpose of Part 1 is to
evaluate safety and tolerability and to establish the effect of multiple doses of
lopinavir/ritonavir on isavuconazole.
Part 2, if initiated, includes 54 subjects randomized to receive isavuconazole alone,
lopinavir/ritonavir alone, or isavuconazole in combination with lopinavir/ritonavir.
Reports of Suspected Kaletra (Lopinavir / Ritonavir) Side Effects
Foetal Exposure During Pregnancy (238),
Maternal Exposure During Pregnancy (134),
Premature Baby (90),
Abortion Spontaneous (60),
Atrial Septal Defect (34), more >>