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

  • STATUS
    Recruiting
  • End date
    Feb 14, 2024
  • participants needed
    25
  • sponsor
    Gilead Sciences
Updated on 4 October 2022

Summary

The primary objective of this study is to evaluate safety and tolerability of dual anti-human immunodeficiency virus (HIV) envelope monoclonal antibodies (mAbs), VRC07-523LS and CAP256V2LS, in a sequential regimen with a toll-like receptor (TLR)7 agonist, vesatolimod (VES), when administered in virologically suppressed HIV-1 Clade C-infected women on antiretroviral therapy (ART) and during analytical treatment interruption (ATI).

Details
Condition HIV-1-infection
Treatment Vesatolimod, VRC07523LS, CAP256V2LS
Clinical Study IdentifierNCT05281510
SponsorGilead Sciences
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Females recruited from the Females Rising through Education, Support, and Health (FRESH) acute human immunodeficiency virus (HIV) infection cohort
Plasma HIV-1 ribonucleic acid (RNA) levels < 50 copies/mL at the screening visit
Antiretroviral therapy (ART) initiated at detection of acute HIV-1 infection (Fiebig I-IV)
On 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 and CAP256V2LS at the screening visit

Exclusion Criteria

Positive serum pregnancy test
Nursing females
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 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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