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

Evaluation of Clinical Response and Safety in HIV Positive Subjects Co-infected With Hepatitis C Treated With a Kaletra Containing HAART Regimen

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00234975

Enrollment

Registered

2005-10-10

Start date

2002-10-31

Completion date

2008-01-31

Last updated

2013-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

Keywords

Lopinavir, Ritonavir, Phase 4, HIV

Brief summary

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.

Interventions

DRUGLopinavir/Ritonavir

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Exclusion criteria

Design outcomes

Primary

Measure	Time frame	Description
Primary Outcome Measure	Baseline, Week 4, Week 8, Week 16 and Week 24	Changes in liver functions enzyme.

Secondary

Measure	Time frame	Description
Secondary Outcome Measures	Baseline, Week 4, Week 8, Week 16 and Week 24	Changes in HIV viral load, CD4/CD8 cell count, and Hepatitis C viral load

Countries

Puerto Rico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026