NCT05959707

Brief Summary

Part A: The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses. The study will also evaluate if the antibody is safe to give to people and does not make them too uncomfortable. Part B: The purpose of this part is to study how the body's immune system reacts to a combination of lab-made HIV-1 monoclonal antibodies against HIV antigens when given in different doses. The study also wants to see if the way the antibodies are given affects the immune response.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
77

participants targeted

Target at P75+ for phase_1 hiv-infections

Timeline
Completed

Started Aug 2024

Shorter than P25 for phase_1 hiv-infections

Geographic Reach
1 country

8 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2025

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

July 17, 2023

Last Update Submit

July 2, 2024

Conditions

HIV Infections

Keywords

HIV

Outcome Measures

Primary Outcomes (6)

  • Number of Local and systemic solicited AEs

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

    Through 6 months

  • Number of unsolicited AEs, and SAEs

    Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\]

    Through 6 months

  • Serum concentrations of PGT121.414.LS

    Measured using quantitative immunoassay

    Through 6 months

  • Serum concentrations of VRC01.23LS

    Measured using quantitative immunoassay

    Through 6 months

  • Serum concentrations of PGDM1400LS

    Measured using quantitative immunoassay

    Through 6 months

  • Magnitude of serum neutralizing activity measured with mAb-specific Env-pseudotyped viruses in TZM-bl cells

    Measured using HIV-1-specific nAb assays

    Through 6 months

Secondary Outcomes (6)

  • Serum concentrations of VRC01.23LS

    Through 8 months

  • Serum concentrations of PGT121.414.LS

    Through 8 months

  • Serum concentrations of PGDM1400LS

    Through 8 months

  • Magnitude of serum neutralizing activity measured with Env-pseudotyped viruses in TZM-bl cells

    Through 8 months

  • Magnitude of neutralizing activity against a panel of Env-pseudotyped reference viruses in TZM-bl cells

    Through 8 months

  • +1 more secondary outcomes

Study Arms (8)

VRC01.23LS 5 mg/kg

EXPERIMENTAL

VRC01.23LS 5 mg/kg to be administered via intravenous (IV) infusion at Month 0

Biological: VRC01.23LS

VRC01.23LS 20 mg/kg

EXPERIMENTAL

VRC01.23LS 20 mg/kg to be administered via IV infusion at Month 0

Biological: VRC01.23LS

VRC01.23LS 40 mg/kg

EXPERIMENTAL

VRC01.23LS 40 mg/kg to be administered via IV infusion at Month 0

Biological: VRC01.23LS

VRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg

EXPERIMENTAL

VRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Biological: VRC01.23LSBiological: PGT121.414.LSBiological: PGDM1400LS

VRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg

EXPERIMENTAL

VRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Biological: VRC01.23LSBiological: PGT121.414.LSBiological: PGDM1400LS

VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kg

EXPERIMENTAL

VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Biological: VRC01.23LSBiological: PGT121.414.LSBiological: PGDM1400LS

VRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg

EXPERIMENTAL

VRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Biological: VRC01.23LSBiological: PGT121.414.LSBiological: PGDM1400LS

VRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kg

EXPERIMENTAL

VRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6

Biological: VRC01.23LSBiological: PGT121.414.LSBiological: PGDM1400LS

Interventions

VRC01.23LSBIOLOGICAL

VRC01.23LS will be administered IV over approximately 30 to 60 minutes.

VRC01.23LS 20 mg/kgVRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kgVRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 40 mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 5 mg/kgVRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg
PGT121.414.LSBIOLOGICAL

PGT121.414.LS will be administered IV over approximately 30 to 60 minutes.

VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kgVRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg
PGDM1400LSBIOLOGICAL

PGDM1400LS will be administered IV over approximately 30 to 60 minutes.

VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kgVRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kgVRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kgVRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 18 through 50 years
  • Access to a participating CRS and willingness to be followed for the planned duration of the study
  • Ability and willingness to provide informed consent
  • Assessment of understanding (AoU): volunteer demonstrates understanding of this study and completes a questionnaire prior to first study-product administration with verbal demonstration of understanding of all questionnaire items answered incorrectly
  • Agrees not to enroll in another study of an investigational research agent until completion of the last required protocol clinic visit.
  • Good general health as shown by medical history, physical exam, and screening laboratory tests
  • Willingness to receive HIV test results
  • Willingness to discuss HIV acquisition and amenable to HIV risk-reduction counseling.
  • Assessed by the clinic staff as having a low likelihood of HIV acquisition and is committed to avoid behaviors associated with a higher likelihood of acquiring HIV through the last required protocol clinic visit.
  • Hemoglobin
  • ≥ 11.0 g/dL for AFAB volunteers
  • ≥ 13.0 g/dL for AMAB volunteers and transgender men who have been on hormone therapy for more than 6 consecutive months
  • ≥ 12.0 g/dL for transgender women who have been on hormone therapy for more than 6 consecutive months
  • For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on their sex assigned at birth
  • White blood cell (WBC) count = 2,500 to 12,000 cells/mm3
  • +20 more criteria

You may not qualify if:

  • Weight \< 35 kg or \> 115 kg
  • Blood products received within 120 days before first study-product administration, unless eligibility for earlier enrollment is determined by the HVTN 143/HPTN 109 PSRT
  • Investigational research agents received within 30 days before first study-product administration
  • Intent to participate in another study of an investigational research agent or any other study that requires non-Network HIV Ab testing during the planned duration of the HVTN 143/HPTN 109 study
  • Pregnant or breastfeeding
  • HIV vaccine(s) received in a prior HIV vaccine trial. Volunteers who have received control/placebo in an HIV vaccine trial are not excluded from HVTN 143/HPTN 109.
  • SARS-CoV-2 vaccine(s) received within 7 days prior to HVTN 143/HPTN 109 enrollment or planned within 7 days after enrollment.
  • Jynneos vaccine for MPOX received within 14 days prior to enrollment or planned within 14 days after enrollment.
  • ACAM2000 vaccine for MPOX received within 28 days prior to enrollment or, if ACAM2000 was received more than 28 days prior to enrollment, vaccination scab still present; or planned within 14 days after enrollment
  • Receipt of humanized or human mAbs, whether licensed or investigational.
  • Previous receipt of mAbs targeting HIV (eg, cap256, VRC01, VRC01LS, VRC07-523LS, PGDM1400, PGDM1400LS, PGT121, PGT121.414.LS)
  • Serious adverse reactions to VRC01.23LS, PGDM1400LS, or PGT121.414.LS formulation components, including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain.
  • Immunoglobulin received within 60 days before first study-product administration (for mAb, see criterion 10 above)
  • Immunodeficiency
  • Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Groote Schuur HIV CRS

Cape Town, Western Cape, 7925, South Africa

Location

Emavundleni CRS

Klipfontein, Western Cape, 7750, South Africa

Location

CAPRISA eThekwini CRS

Durban, South Africa

Location

Soweto HPTN CRS

Johannesburg, 1864, South Africa

Location

Ward 21 CRS

Johannesburg, 2001, South Africa

Location

Klerksdorp CRS

Klerksdorp, South Africa

Location

Isipingo CRS

KwaZulu, 4110, South Africa

Location

Soshanguve

Soshanguve, South Africa

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Hyman Scott

    Bridge HIV

    STUDY CHAIR

  • Cynthia Gay

    University of North Carolina

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2023

First Posted

July 25, 2023

Study Start

August 14, 2024

Primary Completion

January 14, 2025

Study Completion

January 14, 2025

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

ZA(8)