Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

Status Not yet recruiting

Clinical Trial Summary

This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection

Clinical Trial Description

In our study, both efficacy and safety of raltegravir(RAL)-based therapy will be assessed. 300 treatment-experienced patients with drug-resistant HIV will be randomized to two arms (2:1). Group A (n=200) will be assigned with RAL-based regimen (RAL+TDF+LPV/r).Group B (n=100) will be assigned with current second-line regimen in China (3TC+TDF+LPV/r). Both virological and immunological profiles and responses at baseline and at week 4, 8, 12, 24, 36, and 48 will be evaluated. This study will be the first large-scale, multicenter, randomized, prospective RAL-based therapy study in China for HIV/AIDs patients. The result will provide proves for further practical antiviral therapy for China or other resource-limiting countries. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

AIDS/HIV PROBLEM

Clinical Trial Details

NCT number	NCT01844310
Study type	Interventional
Source	Peking Union Medical College
Contact	Taisheng 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

View Details

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