Study Details

OVERVIEW

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

Participation Requirements

Age

18 Years +

Sex

Female

Healthy Volunteers

Medical Condition

HIV-1-infection

Gender

N/A

Date

June 2022 - March 2025

Study Type

Interventional

Study Phase

Phase 2

Product

Vesatolimod, VRC07523LS, CAP256V2LS

Eligibility Information

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.

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.

Locations

Locations (1)

FRESH Clinical Research Site: Females Rising through Education, Support and Health

Umlazi, South Africa, 4066

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