HIV-1-infection Clinical Trial
Official title:
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
Verified date | January 2024 |
Source | Gilead Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 21 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
South Africa | FRESH Clinical Research Site: Females Rising through Education, Support and Health | Umlazi |
Lead Sponsor | Collaborator |
---|---|
Gilead Sciences |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) | First dose date up to 60 weeks | ||
Primary | Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities | First dose date up to 60 weeks | ||
Secondary | Time to Viral Rebound (confirmed = 50 copies/mL and = 200 copies/mL) Following Analytical Treatment Interruption (ATI) | Up to 60 weeks | ||
Secondary | The Change in Plasma Viral Load Set-point Following ATI | Pre-antiretroviral therapy (ART) (Screening) and prior to ART reinitiation following ATI (maximum of 60 weeks) | ||
Secondary | Viral Load at the End of ATI | Up to 60 weeks | ||
Secondary | Time to Antiretroviral Therapy (ART) Resumption Following ATI | Up to 60 weeks | ||
Secondary | Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod (VES) | Cmax is defined as maximum observed concentration of drug. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: Tmax of VES | Tmax is defined as time (observed time point) of Cmax. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: Clast of VES | Clast is defined as last observed quantifiable concentration of the drug. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: Tlast of VES | Tlast is defined as time (observed time point) of Clast. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: AUCinf of VES | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/?z). | Predose up to 48 hours postdose | |
Secondary | PK Parameter: AUClast of VES | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: AUCexp of VES | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: t1/2 of VES | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (?z). | Predose up to 48 hours postdose | |
Secondary | PK Parameter: CL/F of VES | CL/F is defined as clearance following extravascular administration. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: Vz/F of VES | Vz/F is defined as apparent volume of distribution. | Predose up to 48 hours postdose | |
Secondary | PK Parameter: Cmax of VRC07-523LS and CAP256V2LS | Cmax is defined as maximum observed concentration of drug. | Predose up to Day 413 | |
Secondary | PK Parameter: Tmax of VRC07-523LS and CAP256V2LS | Tmax is defined as time (observed time point) of Cmax. | Predose up to Day 413 | |
Secondary | PK Parameter: Clast of VRC07-523LS and CAP256V2LS | Clast is defined as last observed quantifiable concentration of the drug. | Predose up to Day 413 | |
Secondary | PK Parameter: Tlast of VRC07-523LS and CAP256V2LS | Tlast is defined as time (observed time point) of Clast. | Predose up to Day 413 | |
Secondary | PK Parameter: AUCinf of VRC07-523LS and CAP256V2LS | AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/?z). | Predose up to Day 413 | |
Secondary | PK Parameter: AUClast of VRC07-523LS and CAP256V2LS | AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. | Predose up to Day 413 | |
Secondary | PK Parameter: AUCexp of VRC07-523LS and CAP256V2LS | AUCexp is defined as AUC extrapolated between AUClast and AUCinf. | Predose up to Day 413 | |
Secondary | PK Parameter: t1/2 of VRC07-523LS and CAP256V2LS | t1/2 is defined as estimate of the terminal elimination half-life of the drug, calculated by dividing the natural log of 2 by the terminal elimination rate constant (?z). | Predose up to Day 413 | |
Secondary | PK Parameter: CL of VRC07-523LS and CAP256V2LS | CL is defined as clearance following intravenous administration. | Predose up to Day 413 | |
Secondary | PK Parameter: Vss of VRC07-523LS and CAP256V2LS | Vss is defined as the apparent volume of distribution at steady-state. | Predose up to Day 413 | |
Secondary | PK Parameter: Vz of VRC07-523LS and CAP256V2LS | Vz is defined as volume of distribution of the drug after intravenous administration. | Predose up to Day 413 | |
Secondary | Percentage of Participants With Positive Anti-VRC07-523LS Antibodies | Prebaseline (Day -13) up to Day 413 | ||
Secondary | Percentage of Participants With Positive Anti-CAP256V2LS Antibodies | Prebaseline (Day -13) up to Day 413 |
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