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Lopinavir Medical Research Studies

Up-to-date List of Lopinavir Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Lopinavir Medical Research Studies

Rank Status Study
1 Not yet recruiting Pharmacokinetic Study of Super-boosted Lopinavir/Ritonavir Given With Rifampin
Conditions: AIDS;   Tuberculosis
Intervention: Drug: Lopinavir/ritonavir and ritonavir
Outcome Measures: Proportion of patients with expected Cmax of rifampin.;   Proportion of patients with expected pre dose concentration of Lopinavir.;   Proportion of patients with successful treatment of HIV therapy.;   Proportion of patients with expected AUC of rifampin;   Proportion of patient with success of tuberculosis therapy;   Proportion of patients with expected Cmax and AUC of Lopinavir
2 Recruiting Pilot Simplification Study to Lopinavir/Ritonavir 800/200 mg Monotherapy Regimen Once Daily
Condition: HIV
Intervention: Drug: Lopinavir/ritonavir 800 mg / 200mg
Outcome Measures: plasma viral load <40 copies/mL;   Stability in the plasma levels of Lopinavir/ritonavir during all study visits;   Tolerability;   Adherence;   Satisfaction;   - Efficacy in CSF
3 Unknown  Lopinavir/Ritonavir (LPV/r) Tablet in HIV Infected Children
Condition: HIV-1 Infection
Intervention: Other: Lopinavir/ritonavir
Outcome Measure: assess the level of Lopinavir trough level >1 mg/L in low dose Lopinavir (reduction by 70%)
4 Unknown  An Evaluation of the Pharmacological Interaction of Lopinavir/r and Rifampin
Conditions: HIV Infection;   Tuberculosis
Intervention: Drug: Rifampin
Outcome Measures: Plasma levels of rifampin and Lopinavir-ritonavir (pharmacokinetics).;   HIV response to treatment;   Adverse events
5 Unknown  High Dose Ritonavir/Lopinavir Liquid Formulation in Salvage Therapy for Protease Inhibitor Resistant HIV Disease
Conditions: HIV;   AIDS
Intervention: Drug: Kaletra (drug)
Outcome Measures: To evaluate the safety and efficacy of high dose kaletra liquid and capsules in the treatment of highly antiretroviral experienced, protease inhibitor resistant HIV disease.;   To compare traditional pharmacokinetic measures of the two formulations (kaletra liquid and kaletra capsules) in a subset of the patients included in the primary analysis.
6 Unknown  Pilot Assessment of Lopinavir/Ritonavir and Maraviroc
Conditions: HIV Infections;   Acquired Immunodeficiency Syndrome
Intervention: Drug: Lopinavir/ritonavir plus maraviroc
Outcome Measures: Virologic response defined as viral load reduction of >/= 1 log;   Assess proportion of patients with HIV-1 viral load < 48 copies;   Assess time to loss of virologic response;   Assess development of resistance mutations in patients who develop rebound;   Compare serum lipid profile changes;   Assess safety and tolerability;   Assess degree of immune reconstitution
7 Unknown  Pilot Study of Effect of Kaletra on CD4 Response in HIV Positive (+) Patients With Viral Suppression KIMBO Study
Condition: HIV
Intervention: Drug: Lopinavir/Ritonavir
Outcome Measures: Absolute change in CD4 cell count from baseline, and at 6 and 12 months;   Changes from baseline in CD4 cell percentage at 6 and 12 months;   Changes from baseline in CD4 cell count at 6 and 12 months;   Baseline will be defined as the mean of 2 values obtained prior to the medication switch (for analysis purposes, the CD4 cell counts at 6 and 12 months will be defined by the mean of the CD4 cell counts obtained at months 3, 6 or 9, 12, respectively).;   Changes in the slope of CD4 as assessed 6 months prior to the Lopinavir/ritonavir switch (baseline), compared to 6-12 month intervals post initiation of Lopinavir/ritonavir (slope 1-6 months, 1-12 months)
8 Unknown  Study of the 48-Week Virologic and Immunologic Response to Lopinavir/Ritonavir (Kaletra) in HIV Positive Adult Patients
Condition: HIV Infections
Intervention: Drug: Kaletra
Outcome Measures: Proportion of patients with plasma HIV-1 RNA <400 copies/mL at Week 24 and 48;   Proportion of patients with plasma HIV-1 RNA < 50 copies/mL at Week 48;   Proportion of patients with plasma HIV-1 RNA <400 copies/mL or <50 copies/mL at each study visit;   Proportion of patients with plasma HIV-1 RNA <50 copies/mL at Weeks 24 and 48 Weeks;   Number of weeks until HIV RNA <400 copies/mL and <50 copies/mL, respectively;   Change from baseline to each study visit in plasma HIV-1 RNA and CD4+ cell count;   Time-averaged change from baseline to Weeks 12, 24 and 48 (AUCMB) in plasma HIV-1 RNA and CD4+cell count;   Change in HIV genotype and phenotype in patients who either intensify study therapy or experience virologic rebound;   HIV genomic sequence in treatment failures;   Adverse events and treatment-limiting toxicities at all time points;   Baseline and on-therapy assessment of clinical laboratory parameters;   Change from baseline over time in clinical laboratory parameters including fasted triglycerides, total cholesterol, direct HDL cholesterol and LDL cholesterol
9 Recruiting Drug Interaction Study With Darunavir/Ritonavir or Lopinavir/Ritonavir and Daclatasvir
Condition: Hepatitis C
Interventions: Drug: Daclatasvir;   Drug: Darunavir;   Drug: Ritonavir;   Drug: Lopinavir/Ritonavir
Outcome Measures: Maximum observed plasma concentration (Cmax) for Daclatasvir (DCV) with and without coadministered DRV/RTV or LPV/RTV;   Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV with and without coadministered DRV/RTV or LPV/RTV;   Safety and tolerability endpoints include incidence of Adverse Event (AEs), serious adverse events, AEs leading to discontinuation, deaths, and the results of vital signs, Electrocardiogram (ECGs), physical examinations, and clinical laboratory tests;   Time of maximum observed plasma concentration (Tmax) of DCV;   Plasma concentration observed at 24 hours postdose (C24) of DCV;   Trough observed plasma concentration (Ctrough) of DCV;   Dose-normalized Cmax (Cmax/D) of DCV;   Dose-normalized AUC(TAU) (AUC(TAU)/D) of DCV;   Dose-normalized C24 (C24/D) of DCV
10 Unknown  Pharmacokinetics (PK) and Safety of 2 Different Doses of Lopinavir/Ritonavir in in HIV/Tuberculosis (TB) Co-infected Patients Receiving Rifampicin Containing Anti-tuberculosis Therapy
Conditions: HIV Infections;   Tuberculosis
Intervention: Drug: LPV/r
Outcome Measures: plasma concentration level;   toxicity;   CD4;   HIV RNA;   genotypic resistant
11 Recruiting Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1:FOVIR+EMTRICITABINA + Lopinavir/RITONAVIR VS TENOFOVIR+EMTRICITABINA + MARAVIROC (MARAVI-PEP)
Condition: HIV Infection
Interventions: Drug: Tenofovir, emtricitabine, maraviroc;   Drug: Tenofovir, emtricitabine, Lopinavir/r
Outcome Measure: Proportion of patients reaching 28 days of postexposure prophylaxis.
12 Recruiting Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in HIV
Conditions: HIV Infection;   Tuberculosis
Interventions: Drug: Lopinavir/Ritonavir;   Drug: Raltegravir;   Drug: Isoniazid;   Drug: Pyridoxine;   Drug: Pyrazinamide;   Drug: Ethambutol;   Drug: Rifabutin;   Drug: Rifampin
Outcome Measures: Percent of participants whose HIV viral load was less than 400 copies/mL (Arm B vs Arm A and Arm B vs Arm C);   Percent of participants who experienced mycobacterial culture conversion (Arm B vs Arm A and Arm B vs Arm C);   Percent of participants who experienced TB treatment failure (Arm B vs Arm A and Arm B vs Arm C);   Percent of participants who experienced TB relapse/recurrence (Arm B vs Arm A and Arm B vs Arm C);   Percent of participants whose HIV viral load was less than 50 copies/mL (Arm B vs Arm A and Arm B vs Arm C);   Percent of participants whose HIV viral load was less than 400 copies/mL (Arm A vs Arm C);   Percent of participants whose HIV viral load was less than 50 copies/mL (Arm A vs Arm C);   Percent of participants reporting a grade 3 or 4 adverse event or laboratory abnormality recurrence;   Percent of participants who interrupted or discontinued at least one HIV drug due to toxicity;   Percent of participants who interrupted or discontinued at least one TB drug due to toxicity;   Percent of participants who experienced HIV virologic failure;   Percent of participants who experienced TB IRIS;   CD4 count change from randomization;   Percent of participants who experienced a new AIDS-defining illness;   Percent of participants who experienced death;   Percent of participants who experienced a new AIDS-defining illness or death;   Time to HIV virologic failure
13 Not yet recruiting Evaluation of a Maintenance Strategy With Protease Inhibitors With or Without Lamivudine in Virologically Suppressed HIV Patients on Second Line Antiretroviral Treatment in Africa
Condition: HIV Infection
Interventions: Drug: monoPI - boosted Lopinavir or boosted darunavir;   Drug: bi therapy - (boosted Lopinavir or boosted darunavir) + lamivudine
Outcome Measures: Proportion of patients in virological failure;   Treatment failure after reintroduction of the baseline NRTI backbone regimen;   Virological response;   The viral resistance;   The clinical course of the HIV infection;   The Immune response;   Tolerability;   Assessment of the adherence;   Changes in anthropometric measures;   Assessment neurocognitive functions;   virological response
14 Recruiting Study Comparing Two Alternatives of Antiretroviral Therapy as Post-exposure Prophylaxis to HIV-1: Tenofovir + Emtricitabine + Lopinavir/Ritonavir Versus Tenofovir + Emtricitabine + Raltegravir (RAL-PEP)
Condition: HIV Infection
Interventions: Drug: Tenofovir, Emtricitabine, Lopinavir/r;   Drug: Tenofovir, Emtricitabine, Raltegravir
Outcome Measure: Proportion of patients dropping out before the 28 days of postexposure prophylaxis
15 Recruiting Study to Evaluate the Activity and Tolerability of Lopinavir/Ritonavir and Lamivudine Bitherapy in HIV Patients With Viral Suppression
Condition: HIV Infection
Intervention: Drug: antiretroviral treatment
Outcome Measures: Proportion of patients with no treatment failure;   Proportion of patients with no viral failure;   Proportion of patients with no therapeutical failure;   Time to viral failure;   Proportion of patients with blips;   Change from baseline CD4;   Lipidic profile change from baseline;   Creatinine clearance change from baseline;   Proportion of patients with proximal tubular renal disfunction;   Lipodystrophy changes from baseline;   Adherence to treatment;   Mortality and progression to AIDS;   Adverse events per treatment branch;   Proportion of patients switching study treatment due to an adverse event;   Proportion of serious adverse events related to treatment
16 Unknown  A Pilot Study of Kaletra and Intelence Tablets in Naive Subjects
Condition: HIV Infections
Intervention: Drug: Kaletra and Intelence Tablets
Outcome Measures: Proportion of patients with plasma HIV-1 RNA < 400 copies/mL at weeks 24 and 48;   Proportion of patients with plasma HIV-1 RNA < 75 copies/mL at weeks 24 and 48;   Proportion of patients with plasma HIV-1 RNA < 400 copies/mL or < 75 copies/mL at each study visit;   Number of weeks until HIV RNA < 400 copies/mL and < 75 copies/mL, respectively
17 Recruiting Kaletra in Combination With Antiretroviral Agents
Condition: Human Immunodeficiency Virus
Intervention:
Outcome Measures: To assess the tolerability of Lopinavir/ritonavir in combination with new substances.;   Number of patients with resistance against PI (protease inhibitor);   Number of patients with resistance against INI (integrase inhibitor);   Number of patients with resistance against NNRTI (non-nucleoside reverse transcriptase inhibitor);   Number of patients with (partial) resistance to CCR5 antagonists;   Number of patients with (partial) resistance to CCR5 antagonists.;   Change in CD4 T-cell count
18 Unknown  Lopinavir/Ritonavir Monotherapy Versus Standard Highly Active Antiretroviral Therapy (HAART) in HIV/HCV Coinfected Antiretroviral (ARV) Naive Patients Starting Treatment With Anti-HCV Therapy
Conditions: HIV Infections;   Hepatitis C
Interventions: Drug: LPV/r;   Drug: Nucleoside Reverse Transcriptase Inhibitors;   Drug: PEG-IFNa 2a;   Drug: Ribavirin
Outcome Measures: To assess if the combination of LPV/r monotherapy in association with;   anti-HCV therapy (PEG IFN alfa 2a + Ribavirin) does not match with additional;   toxicity induced by the combination of optimized HAART (Lopinavir/ritonavir + selected Nucs) and PEG-IFN alfa 2a+Ribavirin;   in patients naïve for HIV and HCV;   To assess if LPV/r monotherapy during the HCV treatment;   is associated with anti HIV efficacy and a better patient satisfaction;   vs optimized HAART.
19 Recruiting RAltegravir Switch STudy: Effects on Endothelial Recovery
Conditions: HIV Infection;   Endothelial Dysfunction
Intervention: Drug: raltegravir
Outcome Measures: Change in flow mediated dilatation (FMD) of the brachial artery;   Change in markers of chronic inflammation;   Change in markers of immune activation;   Change in markers of endothelial function;   Changes in plasma HIV-RNA below 50 copies/ml
20 Not yet recruiting A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome
Condition: Severe Acute Respiratory Syndrome
Intervention: Drug: Lopinavir / Ritonavir plus Ribavirin
Outcome Measures: Development of severe SARS;   Adverse events;   SARS-CoV Viral load;   Immunological profile

These studies may lead to new treatments and are adding insight into Lopinavir etiology and treatment.

A major focus of Lopinavir research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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