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Completed

NCT Number: NCT05281510

Study of VRC07-523LS, CAP256V2LS, and 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).

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Key information

Conditions

HIV-1-infection

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Umlazi, 4066, South Africa

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vesatolimod

Drug

Administered orally

Other names: GS-9620

VRC07523LS

Biological

Administered intravenously

CAP256V2LS

Biological

Administered intravenously

Primary outcomes

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

    Time frame: Up to 61.1 weeks

    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.

  2. Percentage of Participants Experiencing Treatment-emergent Graded Laboratory Abnormalities

    Time frame: Up to 61.1 weeks

    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.

Secondary outcomes

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

    Time frame: Up to 56 weeks

    Virologic rebound is defined as at any visit a rebound in HIV-1 RNA to ≥ 50 copies/mL or ≥ 200 copies/mL, which is subsequently confirmed at the following scheduled or unscheduled visit. Time to rebound (in weeks) = (date of rebound or censoring date - ATI start date + 1) / 7.

  2. Change in Plasma Viral Load Set-point Following ATI

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

    Change in plasma viral load set-point between pre-ART value and prior to ART reinitiation following ATI was summarized.

    The pre-ART set point value is the HIV-RNA load count prior to start of initial ARV treatment recorded in the clinical database.

  3. Change From Baseline of Viral Load at the End of ATI

    Time frame: Up to 48 weeks

    Baseline value was the last available value collected on or prior to first dose of study drug.

  4. Time to ART Resumption Following ATI

    Time frame: Up to 56 weeks

    Time to ART resumption (in weeks) = (date of restart ART after ATI period start or censoring date - ATI start date + 1) / 7.

  5. Pharmacokinetic (PK) Parameter of VES: Cmax

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

    Cmax is defined as maximum observed concentration of drug.

  6. PK Parameter of VES: Tmax

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

    Tmax is defined as time (observed time point) of Cmax.

  7. PK Parameter of VES: Clast

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

    Clast is defined as last observed quantifiable concentration of the drug.

  8. PK Parameter of VES: Tlast

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

    Tlast is defined as time (observed time point) of Clast.

  9. PK Parameter of VES: AUCinf

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

    AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).

  10. PK Parameter of VES: AUClast

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

    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

  11. PK Parameter of VES: AUCexp

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

    AUCexp is defined as AUC extrapolated between AUClast and AUCinf.

  12. PK Parameter of VES: t1/2

    Time frame: Day 1: Predose (≤ 5 minutes prior to dosing), 1, 2, 4, 8, 12, 24, and 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).

  13. PK Parameter of VES: CL/F

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

    CL/F is defined as apparent clearance following extravascular administration.

  14. PK Parameter of VES: Vz/F

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

    Vz/F is defined as apparent volume of distribution during the terminal phase following extravascular administration.

  15. PK Parameter of VRC07-523LS: Cmax

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Cmax is defined as maximum observed concentration of drug.

  16. PK Parameter of VRC07-523LS: Tmax

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Tmax is defined as time (observed time point) of Cmax.

  17. PK Parameter of VRC07-523LS: Clast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Clast is defined as last observed quantifiable concentration of the drug.

  18. PK Parameter of VRC07-523LS: Tlast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Tlast is defined as time (observed time point) of Clast.

  19. PK Parameter of VRC07-523LS: AUCinf

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).

  20. PK Parameter of VRC07-523LS: AUClast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

  21. PK Parameter of VRC07-523LS: AUCexp

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUCexp is defined as AUC extrapolated between AUClast and AUCinf.

  22. PK Parameter of VRC07-523LS: t1/2

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 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).

  23. PK Parameter of VRC07-523LS: Clearance (CL)

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    CL is defined as clearance following intravenous administration.

  24. PK Parameter of VRC07-523LS: Vss

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Vss is defined as the volume of distribution at steady-state following intravenous administration.

  25. PK Parameter of VRC07-523LS: Vz

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration.

  26. PK Parameter of CAP256V2LS: Cmax

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Cmax is defined as maximum observed concentration of drug.

  27. PK Parameter of CAP256V2LS: Tmax

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Tmax is defined as time (observed time point) of Cmax.

  28. PK Parameter of CAP256V2LS: Clast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Clast is defined as last observed quantifiable concentration of the drug.

  29. PK Parameter of CAP256V2LS: Tlast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Tlast is defined as time (observed time point) of Clast.

  30. PK Parameter of CAP256V2LS: AUCinf

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUCinf is defined as area under the concentration versus time curve extrapolated to infinite time, calculated as AUClast + (Clast/λz).

  31. PK Parameter of CAP256V2LS: AUClast

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration.

  32. PK Parameter of CAP256V2LS: AUCexp

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    AUCexp is defined as AUC extrapolated between AUClast and AUCinf.

  33. PK Parameter of CAP256V2LS: t1/2

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 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).

  34. PK Parameter of CAP256V2LS: CL

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    CL is defined as clearance following intravenous administration.

  35. PK Parameter of CAP256V2LS: Vz

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Vz is defined as volume of distribution of the drug during the terminal phase after intravenous administration.

  36. PK Parameter of CAP256V2LS: Vss

    Time frame: Day 7: Predose (0 hours), end of infusion, 1, 2, 4, and 8 hours after end of infusion, and then anytime on Days 8, 9, 14, 21, 28, 56, 84, 112, 133, 161, 189, 217, 245, 273, 301, 329, 343, 371, and 413

    Vss is defined as the volume of distribution at steady-state after intravenous administration.

  37. Percentage of Participants With Treatment-emergent Positive Anti-VRC07-523LS Antibodies

    Time frame: Prebaseline (Day -13) up to Day 413

  38. Percentage of Participants With Treatment-emergent Positive Anti-CAP256V2LS Antibodies

    Time frame: Prebaseline (Day -13) up to Day 413

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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