NCT01074931

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

Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China: A Multicenter Post-Marketing Observational Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Abbott · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

It is planned to enroll approximately 100 patients in total. This will be a multicenter post-marketing observational study in China mainland. Each patient will be observed during his/her lopinavir/ritonavir - containing treatment regimen for a maximum period of 18 months. If the physician decides to permanently discontinue lopinavir/ritonavir before the end of the planned observational period of 18 months, the reason for the discontinuation and the new treatment regimen prescribed will be documented. The next routine follow-up visit will be the termination visit for this patient in this study. This post-marketing observational study will be conducted in a prospective, single-arm, multicenter format. As this study is observational in nature, its follow-up is not interventional and is left to the judgment of each physician within the 18-month period, which defines the survey for each patient. For indicative purpose, follow-up of patients should enable approximately 4 patient visits during this period. These visits will take place at average intervals of 6 months, apart from the first visit following inclusion (usually at the end of the first 3 treatment months) and apart from visits required because of an intercurrent event. If treatment with lopinavir/ritonavir is discontinued, standard practice is to review the patient after a period of 3 months. For these reasons, the most likely visits are defined as "V1", "V2", "V3", "V4" although numbers and dates will depend only on the decision of the physician. As a result, failure to meet these suggested dates will not constitute a deviation of the protocol.

Conditions

• HIV-1 Infections

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2010-02-24
• Last updated: 2011-08-03
• Results posted: 2011-08-03

Locations

5 sites across 1 country: China