Efficacy and Safety of Tenofovir Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy

AIDS/HIV PROBLEM Clinical Trial

Official title: Efficacy and Safety of Tenofovir Disoproxil Fumarate Plus Lamivudine Plus Efavirenz Regimen as First-line Antiretroviral Therapy for ART-naive Chinese Patients With HIV-1 Infection

Status Not yet recruiting

Clinical Trial Summary

This study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (TDF) + lamivudine (3TC) + efavirenz (EFV) regimen in antiretroviral therapy (ART)-naive Chinese HIV/AIDS patients.

Clinical Trial Description

This study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3TC+TDF+EFV in ARV-naive Chinese population.

500 eligible participants will be recruited to take the regimen If the patient fails to tolerate EFV, it can be substituted by NVP when CD4 < 250/μL, and by LPV/r when CD4 > 250/uL. If the patient fails to tolerate TDF, AZT will be an alternative, except when Hb < 90/L or neutrophil count < 0.75×109/L. The participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years.

The efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. The safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AIDS/HIV PROBLEM

• NCT number: NCT01844297
• Study type: Interventional
• Source: Peking Union Medical College
• Contact: Tai sheng Li, MD
• Phone: 86-10-69155086
• Email: litsh@263.net
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2013
• Completion date: December 2015