Lopinavir/Ritonavir: Kaletra, Aluvia

CSR Synopses following approval of a new medicine or a new indication for an approved medicine in the US or EU. We are making CSR synopses available to supplement the public information available to patients and healthcare providers about the results of our clinical trials and the evidence used to approve a new medicine or a new indication.

{m} Entries

Phase
Study Indication or Disease
Study Name
P13-566 AbbVie_IU_icons_outlined_v3 HIV Infection PMOS Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS)
P06-131 AbbVie_IU_icons_outlined_v3 HIV Infection PMOS Use of KALETRA® tablets in adult HIV-infected patients: Data from the multicenter Star/Stella cohort
M01-347 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG Evaluation of Single and Multiple Dose Pharmacokinetics of Lopinavir/Ritonavir in HIV Infected Subjects with Mild and Moderate H…
PUER-01-001 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG Factors associated with adherence in a cohort of mv positive subjects on a first time PI containing HAART regimen: Observational study of the impact of adherence on viral load for a HAART regimen containing Kaletra vs. other selected PI containing HAART regimen
M02-418 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG A Randomized Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir DF and Emtricitabine vs. 400 mg Lopinavir/100 mg Ritonavir BID in Combination with Tenofovir DF and Emtricitabine in HIV-Infected Antiretroviral-Naïve Subjects
M10-336 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 A Randomized, Open-label, Study of Lopinavir/Ritonavir 400/100 mg Tablet Twice-Daily + Co-formulated Emtricitabine/Tenofovir Disoproxil Fumarate 200/300 mg Once-Daily Versus Lopinavir/Ritonavir 400/100 mg Tablet Twice-Daily + Raltegravir 400 mg Twice-Daily in Antiretroviral Naive, HIV-1 Infected Subjects
FRAN-03-001 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Vers…
M06-802 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 A phase 3, randomized, open label study, of lopinavir/ritonavir tablets 800/200 mg once-daily versus 400/100 mg twice-daily when coadministered with nucleoside/nucleotide reverse transcriptase inhibitors in antiretroviral-experienced, HIV-1 infected subjects
P12-760 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 4 Drug Use Investigation of Kaletra Tablets (Quaque Die, QD) on Patients With HIV-infection lopinavir-ritonavir, Kaletra, Human Immunodeficiency Virus, HIV, Phase IV, Phase 4, Observational
M05-730 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 A Phase 3, Randomized, Open-label, Study of Lopinavir/ritonavir Tablets Versus Soft Gel Capsules and Once Daily Versus Twice Daily Administration, when Coadministered with NRTIs in Antiretroviral Naive HIV-1 Infected Subjects
M00-154 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG A Phase I/II, Open Label Study to Evaluate the Ability of Combination Therapy with ABT-378/ritonavir (Kaletra®), lamivudine (Epi…
ITAL-04-002 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 KALEAD 1 - A Phase III, Open-label, Randomized, Comparative study of the Antiviral Efficacy of ARV Therapy with Lopinavir/Ritonavir (LPV/r - Kaletra®) in Combination with Tenofovir Versus SOC (Kaletra® in combination with 2 nucleoside RTIs) in Naïve HIV-1 Positive Patients
M02-418 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 A Randomized Open-Label Study of 800 mg Lopinavir/200 mg Ritonavir QD in Combination with Tenofovir DF and Emtricitabine vs. 400 mg Lopinavir/100 mg Ritonavir BID in Combination with Tenofovir DF and Emtricitabine in HIV-Infected Antiretroviral-Naive Subjects
P11-068 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus PMOS Post-Marketing Surveillance of Safety and Efficacy of Kaletra® Tablet in Korean Patients under the “New Drug Re-Examination”
M01-384 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 2 A Phase 2 Study of Lopinavir/Ritonavir in Combination with Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic Toxicities in Antiretroviral HIV-1 Infected Subjects
PUER-02-003 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 4 Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected with Hepatitis C Treated with a Kaletra Containing HAART Regimen
P11-021 AbbVie_IU_icons_outlined_v3 HIV Infection PMOS Use of KALETRA in combination with new substances in adult HIV-infected patients: Data from the German multicenter PROTEKT cohort
M03-613 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG A Randomized, Open-Label Study Assessing Safety, Tolerability, Efficacy, and Metabolic Effects of a Simplified Lopinavir/Ritonavir-Based Induction/Maintenance Therapy in Antiretroviral-Naïve HIV-Infected Subjects
M97-720 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG Phase I/II Study of ABT-378/Ritonavir in Combination with Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-Infected…
M99-049 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG A Randomized, Open-Label, Phase II Study of High Dose ABT 378/Ritonavir and Standard Dose ABT-378/Ritonavir with Additional Rito…
M01-384 AbbVie_IU_icons_outlined_v3 HIV Infection CSR.ORG Phase II Study of Lopinavir/Ritonavir in Combination with Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic To...
M97-720 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 2 Phase I/II Study of ABT-378/Ritonavir in Combination with Reverse Transcriptase Inhibitors in Antiretroviral Naive HIV-1 Infected Subjects
FRAN03-001 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus Phase 3 A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir /Ritonavir Single-Drug Regimen Versus Lopinavir /Ritonavir in Combination with Lamivudine/Zidovudine in Antiretroviral Naïve Patients.
P15-452 AbbVie_IU_icons_outlined_v3 Human Immunodeficiency Virus PMOS ProSpective, MultI-Center, Observational PrograM to Assess the Effectiveness of Dual TheraPy (Lopinavir/Ritonavir + LamivudinE) in Treatment-Experienced HIV Infected Patients in the Routine Clinical Settings of the Russian Federation (SIMPLE)