A Phase 2a Study to Evaluate the Safety and Tolerability of a Regimen of Dual Anti-HIV Envelope Antibodies, VRC07-523LS and CAP256V2LS, in a Sequential Regimen With a TLR7 Agonist, Vesatolimod, in Early Antiretroviral-Treated HIV-1 Clade C-Infected Women

GS-US-382-5445

The goals of this clinical study are to learn more about the study drugs, VRC07-523LS, CAP256V2LS, and vesatolimod (VES) and how safe it is in women that have HIV and are on antiretroviral therapy (ART).

2022-06-09

2025-03-01

2025-03-01

Active (not recruiting)

Early phase I

21

Key Inclusion Criteria: * Age ≥ 18 years * Females recruited from the Females Rising through Education, Support, and Health (FRESH) acute human immunodeficiency virus (HIV) infection cohort. * Plasma human immunodeficiency -1 (HIV-1) ribonucleic acid (RNA) levels \< 50 copies/mL at the screening visit. * On antiretroviral (ART) regimen for ≥ 12 consecutive months prior to the screening visit. * Have all the following laboratory values at the screening visit: * Hemoglobin ≥ 10.0 g/dL * White blood cells ≥ 2500 cells/μL * Platelets ≥ 125,000/mL * Absolute neutrophil counts ≥ 1000 cells/μL * Cluster of differentiation (CD)4+ T cell count ≥ 500 cells/μL * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin ≤ 2 × upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * Women of childbearing potential to have documentation of agreement to follow study contraceptive requirements. * Documented plasma HIV-1 RNA \< 50 copies/mL for 12 consecutive months prior to the screening visit. * In the judgment of the investigator, be in good general health. * Documented history of viral sensitivity to VRC07-523LS or CAP256V2LS at the screening visit. Key Exclusion Criteria: * Have poor venous access that limits phlebotomy. * Positive serum pregnancy test. * Nursing participants. * Females with coinfection and/or immunosuppression as described below: * Autoimmune disease requiring ongoing immunosuppression * Evidence of chronic hepatitis B virus (HBV) infection * Evidence of current hepatitis C virus (HCV) infection * Documented history of pre-ART CD4+ T cell count nadir \< 200 cells/μL * History of opportunistic illness indicative of Stage 3 HIV * Acute febrile illness within 4 weeks prior to the first dose * Have current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance or individual's safety. * Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or are expected to receive these agents during the study. * Have previous or current receipt of humanized or human monoclonal antibody (mAbs), or polyclonal immunoglobulin. * Have previous history of an antidrug antibodies response to a therapeutic agent. * Have previous receipt of an HIV vaccine. * Received any vaccine or immunomodulatory medication within 4 weeks prior to screening. * Have a history of any of the following: * Significant serious skin disease * Significant drug sensitivity or drug allergy * Known hypersensitivity to the study drugs, metabolites, or formulation excipients * Previous or current history of bleeding disorder, platelet disorder including unexplained acute or chronic thrombocytopenia * Autoimmune diseases including type 1 diabetes mellitus * Have current Class C acquired immunodeficiency syndrome (AIDS)-defining condition. * Have any serious or active medical or psychiatric illness that would interfere with participants treatment, assessment, or compliance with the protocol. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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2024-01-29