Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women

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

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).

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.