HIV-1 Infections Clinical Trial
Official title:
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
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.
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