Study of VRC07-523LS, CAP256V2LS, and 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).


Eligibility Criteria:
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.