Safety of Lopinavir/Ritonavir (Kaletra) in HIV/HCV Co-infected Subjects vs Baseline Liver Biopsy Metavir Score

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate clinical response and safety of a Kaletra containing antiretroviral treatment regimen in HIV positive subjects with HCV coinfection.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Simplified Two Drug Kaletra Regimen vs. Kaletra Triple Drug Standard of Care Regimen in Treatment naïve HIV Infected Patients

NCT00234910

HIV Infection

COMPLETED PHASE3

Efficacy and Safety of Kaletra Monotheraphy Compared to Kaletra Based Triple Therapy to Treat HIV in Antiretroviral Naїve Patients

NCT00234923

HIV Infection

COMPLETED PHASE3

A Study to Assess Effectiveness and Safety of Fixed Dose Combination of Lopinavir/Ritonavir (LPV/r) in Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients After Switching From Kaletra in the Routine Clinical Settings of Russian Federation

NCT04138199

HIV-1 Infection

TERMINATED

Safety Study of Lopinavir/Ritonavir With Raltegravir in HIV-infected Patients

NCT00752037

HIV Infections

COMPLETED PHASE4

Long-term Effectiveness and Safety in Hepatitis-co-infected Patients

NCT01153269

Human Immunodeficiency Virus-Infection

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HCV +

Group Type ACTIVE_COMPARATOR

Lopinavir/Ritonavir

Intervention Type DRUG

400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator

HCV -

Group Type ACTIVE_COMPARATOR

Lopinavir/Ritonavir

Intervention Type DRUG

400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lopinavir/Ritonavir

400 mg/ 100 mg BID. Both arms use Kaletra 400/100 mg BID, plus NRTI chosen by the investigator

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-378, lopinavir/ritonavir, Kaletra

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Documented HIV positive.
* At least 18 years of age.
* Does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis C)
* Subject has not been treated for an active opportunistic infection within 30 days of the baseline visit.
* Subject Has a Karnofsky Score greater than or equal to 70.
* Subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with Kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. Rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in Kaletra concentration during concurrent administration.
* The subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator.
* Subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: Hemoglobin\> 8.0 g/dL; absolute neutrophil count \> 750 cells/mL; Platelet count \> 20,000/mL; ALT or AST \</=10 x upper limit of normal (ULN); Creatinine\< 1.5 x ULN; Triglycerides \</=750 mg/dL.
* Subjects have no evidence of grade III or IV adverse event or laboratory abnormality (except for LFTs).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No