The purpose of this study is to evaluate the efficacy and safety of albuvirtide combined with lopinavir-ritonavir (LPV/r) in HIV-1-infected patients who failed first-line antiretroviral therapy (ART).
This was a 48-week, multi-center, open-label, randomized and controlled, non-inferiority phase 3 clinical trial to evaluate the safety and efficacy of albuvirtide combined with LPV/r in HIV-1 infected patients who failed their first-line ART and had HIV-1 RNA levels ≥ 1000 copies/mL at screening. The trial was conducted in 12 sites in China. Subjects meeting inclusion criteria were randomized in a 1:1 ratio to ABT group and NRTI group, in which the ABT group received albuvirtide and LPV/r combination therapy, and NRTI group received the standard 3-drug regimen of LPV/r + Lamivudine (3TC) + Tenofovir (TDF). If TDF was used in the previous regimen or genotypic resistance histories showed primary mutation to TDF, zidovudine (AZT) or abacavir (ABC) would be used. Albuvirtide was given by weekly intravenous infusion and LPV/r was given twice daily orally. A total of 418 subjects were randomized, of whom 401 received at least one treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
418
albuvirtide 320mg administered intravenously once a week
lopinavir-ritonavir 400/100mg administered orally twice daily
tenofovir 300mg administered orally once daily
302 Hospital People's Liberation Army Of China
Beijing, Beijing Municipality, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital, Capital medical university
Beijing, Beijing Municipality, China
Percentage of participants of virological suppression at Week 48
Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48
Time frame: Through Week 48
Changes of viral load
Changes of HIV-1 RNA relative to baseline at Week 48
Time frame: Baseline to Week 48
Percentage of participants with HIV-1 RNA < 400 copies/mL at Week 48
Percentage of participants with HIV-1 RNA \< 400 copies/mL at Week 48
Time frame: Through Week 48
Changes of CD4 cell count
Changes of CD4 cell count relative to baseline at Week 48
Time frame: Baseline to Week 48
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
lamivudine 300mg administered orally once daily
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
The Third People'S Hospital Of Shenzhen
Shenzhen, Guangdong, China
Henan Infectious Disease Hospital
Zhengzhou, Henan, China
The First Hospital of Changsha
Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
Tangdu Hospital, Fourth Military Medical University
Xi’an, Shanxi, China
...and 2 more locations