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

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.