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Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China

NCT01074931 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 98

Last updated 2011-08-03

Study results available
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Summary

This post-marketing observational study is conducted for obtaining data on clinical, biological and virological outcomes, compliance and tolerability of using a lopinavir/ritonavir (LPV/r) -containing regimen for the treatment of naïve or experienced patients infected with human immunodeficiency virus type 1 (HIV-1) in China.

Although LPV/r is frequently used world-wide, the evaluation of the outcomes, compliance, and tolerance of anti-HIV strategies in real life is still a major challenge in the management of HIV-infected patients who are on a life-long therapy, especially in China.

This study will help to develop effectiveness and safety profile of the lopinavir/ritonavir containing regimen in Chinese HIV-1 infected patients, provide more choices of anti-HIV-1 strategies to Chinese experts and benefits Chinese HIV-1 infected patients.

Conditions

  • HIV-1 Infections

Interventions

DRUG

Lopinavir/ritonavir (Kaletra)

Lopinavir/ritonavir(LPV/r) is an HIV protease inhibitor (PI) that is co-formulated with lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in LPV/r, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir. The assignment of the patient to a lopinavir/ritonavir - containing regimen is not decided in advance by this protocol but falls within current practice and the prescription of lopinavir/ritonavir is clearly separated from the decision to include the patient in this study.

Sponsors & Collaborators

Principal Investigators

  • Jian LI, MD · Abbott (China)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-05-31
Completion
2010-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01074931 on ClinicalTrials.gov