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
PROTOCOL 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).
View moreParticipation requirements
Age
18 years +
Sex
FEMALE
Healthy Volunteers
No
Age
18 years +
Sex
FEMALE
Healthy Volunteers
No
Study details
Medical Condition
HIV-1-infection
Gender
N/A
Date
June 2022 - January 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
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