NCT01844310

Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection

Raltegravir-based Antiretroviral Therapy for Resistant HIV-1 Infection in China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Peking Union Medical College · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• AIDS/HIV PROBLEM

Interventions

Type	Name	Description
DRUG	RAL+TDF+LPV/r	Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
DRUG	3TC+TDF+LPV/r	Group B will be assigned with 3TC+TDF+LPV/r

Timeline

• Start date: 2013-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2013-05-01
• Last updated: 2013-05-01

Locations

1 site across 1 country: China