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NCT03554408

First-in-human Study of 10-1074-LS Alone and in Combination With 3BNC117-LS

Completed Phase 1 Last updated 4 August 2021
What this trial tests

Phase 1 trial testing 10-1074-LS in Human Immunodeficiency Virus in 77 participants. Completed in 4 February 2021.

Timeline
20 June 2018
Primary endpoint
4 February 2021
4 February 2021

Quick facts

Lead sponsorRockefeller University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment77
Start date20 June 2018
Primary completion4 February 2021
Estimated completion4 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rockefeller University

Who can join

Adults 18 to 65, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This first clinical study of 10-1074-LS will evaluate its safety, tolerability and pharmacokinetics profile when administered alone or in combination with 3BNC117-LS to HIV (human immunodeficiency virus) -infected and HIV-uninfected individuals.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Broadly neutralizing antibodies for the treatment and prevention of HIV infection.
    Caskey M. · · 2020 · cited 81× · PMID 31764199 · DOI 10.1097/coh.0000000000000600
  2. Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.
    Mahomed S, Garrett N, Baxter C, Abdool Karim Q, et al · · 2021 · cited 77× · PMID 32604408 · DOI 10.1093/infdis/jiaa377
  3. Safety, pharmacokinetics, and immunogenicity of the combination of the broadly neutralizing anti-HIV-1 antibodies 3BNC117 and 10-1074 in healthy adults: A randomized, phase 1 study.
    Cohen YZ, Butler AL, Millard K, Witmer-Pack M, et al · · 2019 · cited 71× · PMID 31393868 · DOI 10.1371/journal.pone.0219142
  4. Broadly neutralizing monoclonal antibodies for HIV prevention.
    Miner MD, Corey L, Montefiori D. · · 2021 · cited 34× · PMID 34806308 · DOI 10.1002/jia2.25829
  5. Can Broadly Neutralizing HIV-1 Antibodies Help Achieve an ART-Free Remission?
    Hsu DC, Mellors JW, Vasan S. · · 2021 · cited 30× · PMID 34322136 · DOI 10.3389/fimmu.2021.710044
  6. Antibody responses to the HIV-1 envelope high mannose patch.
    Daniels CN, Saunders KO. · · 2019 · cited 28× · PMID 31607367 · DOI 10.1016/bs.ai.2019.08.002
  7. The RIO trial: rationale, design, and the role of community involvement in a randomised placebo-controlled trial of antiretroviral therapy plus dual long-acting HIV-specific broadly neutralising antibodies (bNAbs) in participants diagnosed with recent HIV infection-study protocol
    Lee MJ, Collins S, Babalis D, Johnson N, et al · · 2022 · cited 24× · PMID 35382844 · DOI 10.1186/s13063-022-06151-w
  8. Neutralizing Activity of Broadly Neutralizing anti-HIV-1 Antibodies against Primary African Isolates.
    Lorenzi JCC, Mendoza P, Cohen YZ, Nogueira L, et al · · 2021 · cited 24× · PMID 33298542 · DOI 10.1128/jvi.01909-20

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Other trials of 10-1074-LS

Trials testing the same drug.

Other recruiting trials for Human Immunodeficiency Virus

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Other Rockefeller University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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