- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05281510
Study of VRC07-523LS, CAP256V2LS, and Vesatolimod, in Early Antiretroviral-treated HIV-1 Clade C-infected Women
January 25, 2024 updated by: Gilead Sciences
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
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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
21
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gilead Clinical Study Information Center
- Phone Number: 1-833-445-3230 (GILEAD-0)
- Email: GileadClinicalTrials@gilead.com
Study Locations
-
-
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Umlazi, South Africa, 4066
- FRESH Clinical Research Site: Females Rising through Education, Support and Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VRC07523LS + CAP256V2LS + Vesatolimod (VES)
Participants will receive VES 6 mg (or up to 8 mg) every 2 weeks, for a total of 10 doses + VRC07-523LS and CAP256V2LS 20 mg/kg each on Day 7.
|
Administered orally
Other Names:
Administered intravenously
Administered intravenously
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: First dose date up to 60 weeks
|
First dose date up to 60 weeks
|
Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities
Time Frame: First dose date up to 60 weeks
|
First dose date up to 60 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Viral Rebound (confirmed ≥ 50 copies/mL and ≥ 200 copies/mL) Following Analytical Treatment Interruption (ATI)
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
|
The Change in Plasma Viral Load Set-point Following ATI
Time Frame: Pre-antiretroviral therapy (ART) (Screening) and prior to ART reinitiation following ATI (maximum of 60 weeks)
|
Pre-antiretroviral therapy (ART) (Screening) and prior to ART reinitiation following ATI (maximum of 60 weeks)
|
|
Viral Load at the End of ATI
Time Frame: Up to 60 weeks
|
Up to 60 weeks
|
|
Time to Antiretroviral Therapy (ART) Resumption Following ATI
Time Frame: Up to 60 weeks
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Up to 60 weeks
|
|
Pharmacokinetic (PK) Parameter: Cmax of Vesatolimod (VES)
Time Frame: Predose up to 48 hours postdose
|
Cmax is defined as maximum observed concentration of drug.
|
Predose up to 48 hours postdose
|
PK Parameter: Tmax of VES
Time Frame: Predose up to 48 hours postdose
|
Tmax is defined as time (observed time point) of Cmax.
|
Predose up to 48 hours postdose
|
PK Parameter: Clast of VES
Time Frame: Predose up to 48 hours postdose
|
Clast is defined as last observed quantifiable concentration of the drug.
|
Predose up to 48 hours postdose
|
PK Parameter: Tlast of VES
Time Frame: Predose up to 48 hours postdose
|
Tlast is defined as time (observed time point) of Clast.
|
Predose up to 48 hours postdose
|
PK Parameter: AUCinf of VES
Time Frame: Predose up to 48 hours postdose
|
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
|
Predose up to 48 hours postdose
|
PK Parameter: AUClast of VES
Time Frame: Predose up to 48 hours postdose
|
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
|
PK Parameter: AUCexp of VES
Time Frame: Predose up to 48 hours postdose
|
AUCexp is defined as AUC extrapolated between AUClast and AUCinf.
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Predose up to 48 hours postdose
|
PK Parameter: t1/2 of VES
Time Frame: Predose up to 48 hours postdose
|
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 (λz).
|
Predose up to 48 hours postdose
|
PK Parameter: CL/F of VES
Time Frame: Predose up to 48 hours postdose
|
CL/F is defined as clearance following extravascular administration.
|
Predose up to 48 hours postdose
|
PK Parameter: Vz/F of VES
Time Frame: Predose up to 48 hours postdose
|
Vz/F is defined as apparent volume of distribution.
|
Predose up to 48 hours postdose
|
PK Parameter: Cmax of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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Cmax is defined as maximum observed concentration of drug.
|
Predose up to Day 413
|
PK Parameter: Tmax of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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Tmax is defined as time (observed time point) of Cmax.
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Predose up to Day 413
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PK Parameter: Clast of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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Clast is defined as last observed quantifiable concentration of the drug.
|
Predose up to Day 413
|
PK Parameter: Tlast of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
|
Tlast is defined as time (observed time point) of Clast.
|
Predose up to Day 413
|
PK Parameter: AUCinf of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
|
AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).
|
Predose up to Day 413
|
PK Parameter: AUClast of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
|
AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.
|
Predose up to Day 413
|
PK Parameter: AUCexp of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
|
AUCexp is defined as AUC extrapolated between AUClast and AUCinf.
|
Predose up to Day 413
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PK Parameter: t1/2 of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
|
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 (λz).
|
Predose up to Day 413
|
PK Parameter: CL of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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CL is defined as clearance following intravenous administration.
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Predose up to Day 413
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PK Parameter: Vss of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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Vss is defined as the apparent volume of distribution at steady-state.
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Predose up to Day 413
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PK Parameter: Vz of VRC07-523LS and CAP256V2LS
Time Frame: Predose up to Day 413
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Vz is defined as volume of distribution of the drug after intravenous administration.
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Predose up to Day 413
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Percentage of Participants With Positive Anti-VRC07-523LS Antibodies
Time Frame: Prebaseline (Day -13) up to Day 413
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Prebaseline (Day -13) up to Day 413
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Percentage of Participants With Positive Anti-CAP256V2LS Antibodies
Time Frame: Prebaseline (Day -13) up to Day 413
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Prebaseline (Day -13) up to Day 413
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2022
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
March 7, 2022
First Submitted That Met QC Criteria
March 7, 2022
First Posted (Actual)
March 16, 2022
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 25, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GS-US-382-5445
- DOH-27-082021-8379 (Other Identifier: South African National Clinical Trials Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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