clinical, virological and safety outcomes of a lopinavir/ritonavir-based regimen in hiv-1 infected patients in routine clinical use in china

Conditions: HIV-1 Infections

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.

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.

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

Keywords: lopinavir/ritonavir