The primary objectives are to assess the antiviral activity, clinical safety and tolerability parameters of albuvirtide/3BNC117 combination therapy in reducing HIV-1 viral load during the 1-week induction period treatment period.
This is a Phase 2, multi-center study to evaluate the efficacy, safety, and tolerability of ABT/3BNC117 combination in conjunction with an existing failing antiretroviral therapy (ART) for 1 week, and then with optimized background regimen (OBR) for 24 weeks, respectively. A total of 20 eligible subjects who demonstrate evidence of HIV-1 replication despite ongoing antiretroviral therapy with documented genotypic and/or phenotypic resistance to multiple classes of HIV drugs (3 classes or more) will be enrolled. Patients must have been treated with HAART for at least 6 months and be failing or have recently failed (i.e., in the last 8 weeks) therapy to determine baseline viral load.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
ABT-3BNC117_203 Investigational Site
Canoga Park, California, United States
RECRUITINGABT-3BNC117_203 Investigational Site
San Francisco, California, United States
RECRUITINGABT-3BNC117_203 Investigational Site
Hialeah, Florida, United States
Proportion of participants with ≥0.5 log10 reduction in HIV-1 RNA viral load from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Proportion of participants (%) achieving a viral load reduction of at least 0.5 log from baseline (Day 7)
Time frame: Day 14
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Mean change in HIV-1 RNA levels from Day 7 to Day 14
Time frame: Day 14
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to Day 14 as compared to the control period from Day 0 to Day 7.
Mean change in CD4+/CD8+ T cell count from Day 7 to Day 14
Time frame: Day 14
Percentage of participants achieving HIV-1 RNA <200 copies/mL at the EOT.
Percentage of participants achieving HIV-1 RNA \<200 copies/mL
Time frame: Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) during the course of Treatment Phase
Mean change in HIV-1 RNA levels from Day 0 to EOT
Time frame: Through Week 25/EOT
Mean change in HIV-1 RNA levels (log10 copies/mL) from baseline (Day 7) to EOT.
Mean change in HIV-1 RNA levels from Day 7 to EOT
Time frame: Week 25/EOT
Mean change in CD4+/CD8+ T cell count from baseline (Day 7) to EOT.
Mean change in CD4+/CD8+ T cell count from Day 7 to EOT
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ABT-3BNC117_203 Investigational Site
Orlando, Florida, United States
RECRUITINGABT-3BNC117_203 Investigational Site
West Palm Beach, Florida, United States
RECRUITINGABT-3BNC117_203 Investigational Site
Decatur, Georgia, United States
RECRUITINGABT-3BNC117_203 Investigational Site
St Louis, Missouri, United States
RECRUITINGTime frame: Week 25/EOT