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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

2014-07-23 21:10:00 | BioPortfolio

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 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 the 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.

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 months 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 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.

Study Design

Time Perspective: Prospective

Conditions

HIV-1 Infections

Intervention

Lopinavir/ritonavir (Kaletra)

Location

Site Reference ID/Investigator# 7244
Guangdong
China
510060

Status

Active, not recruiting

Source

Abbott

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:00-0400

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