Clinical trial NCT01074931: Clinical, Virological and Safety Outcomes of a Lopinavir/Ritonavir-Based Regimen in HIV-1 Infected Patients in Routine Clinical Use in China
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV-1 Infections
Keywords: Lopinavir/ritonavir
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-02-24
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital

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.

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

Primary outcomes:
measure: Evolution of the HIV Viral Response
timeFrame: Month 3, 6, 12, 18
measure: Evolution of CD4 Count
timeFrame: Month 3, 6, 12, 18
measure: Evolution of the Tolerance Issues
timeFrame: Month 3, 6, 12, 18
Secondary outcomes:
measure: Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen
timeFrame: Month 3, 6, 12, 18
measure: Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations
timeFrame: Month 3, 6, 12, 18
measure: The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment
timeFrame: Month 3, 6, 12, 18
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Site Reference ID/Investigator# 7244
city: Kunming
country: China
facility: Site Reference ID/Investigator# 27865
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 27864
city: Shenzhen
country: China
facility: Site Reference ID/Investigator# 27863
city: Zhengzhou
country: China
facility: Site Reference ID/Investigator# 27866
Study officials:
affiliation: Abbott (China)
name: Jian LI, MD
role: STUDY_CHAIR
References: