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

NCT ID: NCT01074931

Last Updated: 2011-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 98 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2010-06-30

Brief 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

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

Lopinavir/ritonavir group

This study is a non-interventional, observational study in which lopinavir/ritonavir is prescribed in the usual manner in accordance with the terms of China market authorization with regards to dose, population and indication. It is planned to enroll approximately 100 patients in total.

Lopinavir/ritonavir (Kaletra)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

lopinavir/ritonavir; Kaletra

Eligibility Criteria

Inclusion Criteria

• Patients infected by HIV-1 who are over 18 years old
• Patients who belong to one of the following cohorts:

• Antiretroviral naïve patients
• Antiretroviral experienced patients, irrespective to their immune and viral status and current antiretroviral therapy

Exclusion Criteria

• Patients who have been treated with lopinavir/ritonavir
• Patients who are being treated or will be treated with drugs at risk of interactions with lopinavir/ritonavir
• Patients who are not tolerant to lopinavir/ritonavir
• Patients who have uncontrolled AIDS defining disease
• Patients participating in another clinical trial

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott China

Principal Investigators

Jian LI, MD

Role: STUDY_CHAIR

Abbott (China)

Locations

Site Reference ID/Investigator# 7244

Guangdong, , China

Site Reference ID/Investigator# 27865

Kunming, , China

Site Reference ID/Investigator# 27864

Shanghai, , China

Site Reference ID/Investigator# 27863

Shenzhen, , China

Site Reference ID/Investigator# 27866

Zhengzhou, , China

Countries

China

Other Identifiers

P10-398

Identifier Type: -

Identifier Source: org_study_id