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

Gilead Sciences

Status and phase: Completed; Phase 2

Conditions: HIV-1-infection

Treatments: Biological: CAP256V2LS; Drug: Vesatolimod; Biological: VRC07523LS

Study type: Interventional

Funder types: Industry

Identifiers

NCT05281510

DOH-27-082021-8379 (Other Identifier)

GS-US-382-5445

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

VRC07523LS + CAP256V2LS + Vesatolimod (VES)

Experimental group

Description:

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).

Treatment:

Biological: VRC07523LS

Biological: CAP256V2LS

Drug: Vesatolimod