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

NCT01074931 | Completed Results

• 1 other identifier: P10-398
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 5

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.

Conditions

HIV-1 Infections

Keywords

Lopinavir/ritonavir

Outcome Measures

Primary Outcomes (3)

• Evolution of the HIV Viral Response

  The protocol recommended that HIV viral load tests be performed at baseline and each study visit. Test results indicate the number of HIV-1 ribonucleic acid (RNA) copies per milliliter (mL). The number of participants who underwent testing and had detectable levels (greater than 50 copies/mL) or undetectable levels (less than 50 copies/mL) are presented by subgroup. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.

  Month 3, 6, 12, 18

• Evolution of CD4 Count

  The evolution of participants' CD4-positive (CD4+) T-lymphocyte counts after starting the lopinavir/ritonavir-containing regimen was to be assessed by measuring the number of CD4+ cells at baseline and each subsequent study visit. CD4+ count results are reported as the number of CD4+ cells per cubic millimeter (cmm). Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.

  Month 3, 6, 12, 18

• Evolution of the Tolerance Issues

  At each study visit, treating physicians evaluated participants and used their clinical judgment to determine if they were tolerating the lopinavir/ritonavir-containing regimen. Study visits were to occur at approximately 3, 6, 12, and 18 months after starting treatment. The exact dates of each visit depended on the physician's judgment, so data are reported for Visits 1 through 4 rather than by month.

  Month 3, 6, 12, 18

Secondary Outcomes (3)

• Number of Participants Who Missed Doses, Interrupt or Discontinue Regimen, and Experience Changes in Dosage or of Combination Regimen

  Month 3, 6, 12, 18

• Adverse Events Observed and Development of Lipodystrophy Lesion and Their Locations

  Month 3, 6, 12, 18

• The Duration on Treatment Until Development of an Adverse Event Leading to Treatment Discontinuation or Until Escape From Treatment

  Month 3, 6, 12, 18

Study Arms (1)

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.

Drug: Lopinavir/ritonavir (Kaletra)

Interventions

Lopinavir/ritonavir (Kaletra) 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.

Also known as: lopinavir/ritonavir, Kaletra

Lopinavir/ritonavir group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (5)

Site Reference ID/Investigator# 7244

Guangdong, 510060, China

Location

Site Reference ID/Investigator# 27865

Kunming, 650118, China

Location

Site Reference ID/Investigator# 27864

Shanghai, 201508, China

Location

Site Reference ID/Investigator# 27863

Shenzhen, 518020, China

Location

Site Reference ID/Investigator# 27866

Zhengzhou, 450061, China

Location

MeSH Terms

Interventions

Lopinavir; Ritonavir; lopinavir-ritonavir drug combination

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles

Limitations and Caveats

The location of lipodystrophy was not summarized as there was not a place to record the information on the case report form. Too few participants withdrew from treatment to conduct planned analyses of duration to adverse event(s)/discontinuation.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

1-800-633-9110

Study Officials

• Jian LI, MD

  Abbott (China)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 24, 2010
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 3, 2011
• Results First Posted: August 3, 2011

Record last verified: 2011-07

Locations

CN (5)