This study is to evaluate the safety and efficacy of RAL-based regimen in treatment-experienced patients with resistant HIV infection
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
Group B will be assigned with 3TC+TDF+LPV/r
Peking Union Medical College Hospital
Beijing, China
Percentage of participants with HIV-1 RNA < 400 copies/mL at week 48
Time frame: 48 weeks
Percentage of participants with HIV-1 RNA < 40 copies/mL at week 48
Time frame: 48 weeks
Change from baseline in CD4 count at week 48
Time frame: Baseline and 48 weeks
Incidence of adverse events and laboratory abnormalities in the two treatment arms from baseline to week 48
Time frame: through week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.