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.
Lopinavir/Ritonavir: Kaletra, Aluvia
| Study Name | |||
|---|---|---|---|
| P13-566 | HIV Infection | PMOS | Real-Life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program: A Prospective Observational Cohort Study (KASA PMOS) |
| P06-131 | HIV Infection | PMOS | Use of KALETRA® tablets in adult HIV-infected patients: Data from the multicenter Star/Stella cohort |
| M01-347 | 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 | 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 | 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 | 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 | HIV Infection | CSR.ORG | A Pilot, Open-Label, Randomized, Comparative Study of the Antiviral Efficacy of Lopinavir/Ritonavir Single-Drug Regimen Vers… |
| M06-802 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | HIV Infection | CSR.ORG | Phase II Study of Lopinavir/Ritonavir in Combination with Saquinavir Mesylate or Lamivudine/Zidovudine to Explore Metabolic To... |
| M97-720 | 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 | 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. |
No results found