study of vrc07-523ls, cap256v2ls, and vesatolimod, in early antiretroviral-treated hiv-1 clade c-infected women

Conditions: HIV-1-infection

Summary: 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.