bNAbs and Anti-PD-1 in HIV

Sponsor
Ole Schmeltz Søgaard
Study ID
NCT07820813
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • HIV-1

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 3BNC117-LS — DRUG
    bNAb; 30 mg/kg
  • 10-1074-LS — DRUG
    bNAb; 10 mg/kg
  • Nivolumab — DRUG
    Anti-PD-1a; low dose 1.0 mg/kg
  • Placebo — OTHER
    Saline

Study Details

Antiretroviral therapy (ART) has significantly extended the life expectancy of people living with HIV-1 (PLWH), but it does not cure the infection. Broadly neutralizing antibodies (bNAbs), such as 3BNC117 and 10-1074, not only neutralize circulating virus but also engage the immune system to enhance HIV-1-specific CD8+ T cell responses and stimulate autologous neutralizing antibody production. In some individuals who discontinue ART, bNAb treatment resulted in long-term post-treatment control. However, a major obstacle to immunotherapeutic strategies in PLWH is the immune dysfunction that persists despite long-term suppressive ART. One contributing factor is the immune checkpoint receptor programmed death-1 (PD-1), which is expressed on T cells and suppresses their function when engaged by its ligands. Blocking PD-1 with monoclonal antibodies (mAbs) can reverse T cell exhaustion, a strategy that has resulted in extraordinary increases in survival and cure in cancer treatment and in ex vivo and animal studies of HIV. These findings support the rationale for incorporating PD-1 inhibition in HIV cure strategies. Low-dose nivolumab, an anti-PD-1 mAb, has been shown to be safe in clinical trials. The hypothesis is that combining a single low-dose of nivolumab with long-acting bNAbs (3BNC117-LS and 10-1074-LS) during an analytical treatment interruption (ATI) will reduce T cell exhaustion and boost HIV-1-specific immune responses, as a novel strategy to induce sustained virological control without ART even after the bNAbs have been cleared from the body.

Key Dates

First listed
Sep 15, 2026
Start date
Sep 15, 2026
Status verified
Sep 2026
Primary completion
Sep 15, 2029
Completion
Sep 15, 2030

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: A: bNAbs/anti-PD-1a
    3BNC117-LS, 10-1074-LS and nivolumab
  • Active Comparator: B: bNAbs/placebo
    3BNC117-LS, 10-1074-LS and placebo

Primary Outcome Measure

Time from the day of stopping ART to the day of meeting criteria for loss of immunological control of HIV-1 (defined below) [ Time Frame: 60 weeks ]

Central Contacts

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