This is a phase 2 study to evaluate the safety and tolerability of combination therapy with Albuvirtide (ABT) and 3BNC117 in virologically suppressed subjects with HIV-1 infection and explore the potential of viral suppression and viral reservoir clearance after analytical treatment interruption (ATI).
This is an open-label, one site study, in which a total of 24 HIV-1 subjects who are virologically suppressed and stable on daily oral combination antiretroviral therapy will be enrolled. All eligible patients will be switched from daily oral combination antiretroviral regimen to treatment of ABT and 3BNC117 for 14 weeks. There is a two-week overlap of the baseline oral antiretroviral therapy and the ABT-3BNC117 combination regimen at the beginning of the study treatment, and then the oral ART will be interrupted. The patients will be monitored for viral rebound every two or four weeks following initiation of ABT-3BNC117 combination and will re-initiate an oral antiretroviral regimen if virological rebound is confirmed with plasma HIV-1 RNA levels above 200 copies/ml on two consecutive test. Pharmacokinetics of ABT and 3BNC117 will be assessed in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.
Peking Union Medical College Hospital
Beijing, China
Proportion of participants (with sustained viral suppression at week 14) with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI)
Proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 26.
Time frame: Week 26
Mean time to virologic rebound (HIV-1 RNA≥200 copies/mL) after ATI
Mean time to virologic rebound
Time frame: up to 48 weeks
Proportion of participants without experiencing virologic rebound (HIV-1 RNA<200 copies/mL) at Week 26 (24 weeks after ATI).
Proportion of participants without experiencing virologic rebound
Time frame: Week 26
Proportion of participants with HIV-1 RNA < 50 copies/mL at Week 26 (24 weeks after ATI).
Proportion of participants with HIV-1 RNA \< 50 copies/mL at Week 26
Time frame: Week 26
Mean change in CD4 cell count after ATI
Mean change in CD4 cell count
Time frame: up to 48 weeks
Mean change in CD4/CD8 ration after ATI
Mean change in CD4/CD8 ration
Time frame: up to 48weeks
Frequency of emergence of new resistance mutations after virologic rebound
Frequency of emergence of new resistance mutations
Time frame: up to 48 weeks
Mean time to achieving HIV-1 RNA < 50 copies/mL after experiencing virologic rebound
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mean time to achieving HIV-1 RNA \< 50 copies/mL after experiencing virologic rebound
Time frame: up to 48 weeks