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Kaletra (Lopinavir / Ritonavir) - Summary



KALETRA (lopinavir/ritonavir) is a co-formulation of lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 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-1 infection in adults and pediatric patients (14 days and older).

The following points should be considered when initiating therapy with KALETRA:

  • The use of other active agents with KALETRA is associated with a greater likelihood of treatment response [see Microbiology and Clinical Studies].
  • Genotypic or phenotypic testing and/or treatment history should guide the use of KALETRA [see Microbiology ]. The number of baseline lopinavir resistance-associated substitutions affects the virologic response to KALETRA [see Microbiology].

See all Kaletra indications & dosage >>


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)...

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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 copies/ml). Specifically:

- 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.

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Reports of Suspected Kaletra (Lopinavir / Ritonavir) Side Effects

Foetal Exposure During Pregnancy (238)Maternal Exposure During Pregnancy (134)Premature Baby (90)Stillbirth (61)Abortion Spontaneous (60)Anaemia (49)Diarrhoea (38)Pyrexia (36)Death (36)Atrial Septal Defect (34)more >>

Page last updated: 2011-12-09

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