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

NCT05281510 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-382-5445DOH-27-082021-8379
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

  An AE is any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAE was defined as any AE that began on or after the study drug start date and no later than last exposure date after permanent discontinuation of study drug, or led to premature study drug discontinuation.

  Up to 61.1 weeks

• Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities

  A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the last exposure date after permanent discontinuation of study drug. For maximum postbaseline toxicity grade, the most severe graded abnormality from all tests was counted for each participant. The severity grades were defined by Gilead Grading Scale for Severity of Adverse Events and Laboratory Abnormalities, Antiviral Toxicity Grading Scale, Version 01 April 2015. The CTCAE v5 grading scale was used to grade AEs determined to be cytokine release syndrome and infusion-related reactions. The grading for both scales are as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening, Grade 5 = Death.

  Up to 61.1 weeks

Secondary Outcomes (38)

• Time to Viral Rebound (Confirmed ≥ 50 Copies/mL and ≥ 200 Copies/mL) Following ATI

  Up to 56 weeks

• Change in Plasma Viral Load Set-point Following ATI

  Pre-ART (Screening) and prior to ART reinitiation following ATI (Up to 56 weeks)

• Change From Baseline of Viral Load at the End of ATI

  Up to 48 weeks

• Time to ART Resumption Following ATI

  Up to 56 weeks

• Pharmacokinetic (PK) Parameter of VES: Cmax

  Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 48 hours postdose

Study Arms (1)

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

EXPERIMENTAL

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).

Drug: Vesatolimod; Biological: VRC07523LS; Biological: CAP256V2LS

Interventions

Vesatolimod DRUG

Administered orally

Also known as: GS-9620

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

VRC07523LS BIOLOGICAL

Administered intravenously

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

CAP256V2LS BIOLOGICAL

Administered intravenously

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

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

Umlazi, 4066, South Africa

Location

Related Publications (5)

• 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

  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.

  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.

  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.

  BACKGROUND

• Ahmed A, Hill M, Dong KL, Ngcobo MW, Zulu A, Langa N, Maphalala L, Pillay V, Mthembu M, Tran W, Lau R, Stockman JK, Ndung'u T, Dube K. Stress and Coping During an HIV Cure-Related Trial with an Analytical Treatment Interruption: A Qualitative Assessment of the Experiences of Young Women in Durban, South Africa. J Int Assoc Provid AIDS Care. 2026 Jan-Dec;25:23259582261423985. doi: 10.1177/23259582261423985. Epub 2026 Feb 13.

  PMID: 41685863 DERIVED

Related Links

• Gilead Clinical Trials Website

MeSH Terms

Interventions

vesatolimod

Results Point of Contact

• Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences

GileadClinicalTrials@gilead.com

1-833-445-3230 (GILEAD-0)

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: June 9, 2022
• Primary Completion: January 16, 2025
• Study Completion: January 16, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)