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

NCT ID: NCT05281510

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-09
• Study Completion Date: 2025-01-16

Brief 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).

Conditions

HIV-1-infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

In Period 1 (Days 0-28), participants will receive ART through Period. On Days 0 \& 14, participants will be administered VES 6mg orally and on Day 28, participants will be administered VES either 6 or 8mg orally. VRC07-523LS \& CAP256V2LS 20mg/kg will be administered intravenously on Day 7. In Period 2 (Days 29-133 or until ART restart), participants will discontinue ART at Day 35 and remain off ART until reaching ART restart criteria. Participants will receive VES 6 or 8mg orally every 2 weeks from Day 29 or until plasma HIV-1 RNA is \>=5000 copies/mL. In Period 3, (Days 134-336 or until ART restart), participants will continue ATI and no study treatment will be administered. In Period 4, (Days 337-413) participants who have not met ART restart criteria by Day 337 may choose to restart ART (Period 4a) or may choose to continue ATI until end of study (Period 4B). Any participants who meet ART restart criteria before the end of the study will remain in follow-up on ART (Period 4A).

Group Type: EXPERIMENTAL

Vesatolimod

Intervention Type: DRUG

Administered orally

VRC07523LS

Intervention Type: BIOLOGICAL

Administered intravenously

CAP256V2LS

Intervention Type: BIOLOGICAL

Administered intravenously

Interventions

Vesatolimod

Administered orally

Intervention Type: DRUG

VRC07523LS

Administered intravenously

Intervention Type: BIOLOGICAL

CAP256V2LS

Administered intravenously

Intervention Type: BIOLOGICAL

Other Intervention Names

GS-9620

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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

Umlazi, , South Africa

Countries

South Africa

References

Dong K, Asari V, Govender V, et al. Evaluation of 2 bNAbs plus vesatolimod in early-treated South African women with HIV-1 during ATI [CROI abstract 105]. Top Antivir Med. 2025;33:14

Reference Type: BACKGROUND

Omange RW, Zhang L, Reddy K, et al. Presence of protective human leukocyte antigen class I and II is associated with improved analytical treatment interruption outcomes in a trial of vesatolimod and broadly neutralizing antibodies in South African women with early-treated clade C HIV-1. Presented at the Keystone HIV Cure: Antiretroviral Therapy-Free Control of HIV Infection Symposium; April 7-10, 2025; Durban, South Africa. Poster 2014.

Reference Type: BACKGROUND

Dong K, SenGupta D, Gama L, et al. First HIV cure interventional trial in Africa with collaboration between academia, government, and industry. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. ePoster EP1003.

Reference Type: BACKGROUND

Cai Y, Zhang L, Omange RW, et al. Vesatolimod pharmacodynamic responses in a trial of vesatolimod and broadly neutralizing antibodies in early-treated South African women with clade C HIV-1. Presented at the 13th International AIDS Society (IAS) Conference on HIV Science; July 13-17, 2025; Kigali, Rwanda. Poster WEPEB018.

Reference Type: BACKGROUND

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.gileadclinicaltrials.com/study/?id=GS-US-382-5445

Gilead Clinical Trials Website

Other Identifiers

DOH-27-082021-8379

Identifier Type: OTHER

Identifier Source: secondary_id

GS-US-382-5445

Identifier Type: -

Identifier Source: org_study_id