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Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

Safety and Efficacy of Broadly Neutralizing Antibodies Followed by Innate Immune Stimulation and Therapeutic Vaccination for the Induction of HIV Remission

NCT05769569•Henry M. Jackson Foundation for the Advancement of Military Medicine

View on ClinicalTrials.gov

Summary

This is a phase I, randomized, open-label trial to investigate the safety of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-Bavarian Nordic (BN)-HIV and A244d11gp120/ALFQ vaccination, and the impact on time to sustained viral rebound of ≥1000 copies/mL for 4 consecutive weeks during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who initiated antiretroviral therapy (ART) during acute HIV-1 infection (AHI).

Detailed Description

This is a phase 1 study. The study duration is approximately 134 weeks. The primary objectives are: 1. To evaluate the safety of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-BN-HIV and A244d11 gp120/ALFQ vaccination in PLWH who initiated ART during AHI. 2. To evaluate the impact of VRC07-523LS, PGDM1400LS and N-803 in combination with Ad26.Mos4.HIV, MVA-BN-HIV and A244d11 gp120/ALFQ vaccination on time to sustained viral rebound to ≥1000 copies/mL for 4 consecutive weeks AND has not declined by \>0.2 log10 from the previous measurement during ATI.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants are eligible to be included in the protocol Step 1 only if all of the following criteria are met:
•1. Thai National
•2. Age ≥18 and ≤50 years of age
•3. Can read and write Thai or English
•4. Able and willing to provide written informed consent
•5. Participant of the RV254 study
•6. Confirmed HIV-1 infection (nucleic acid testing \[NAT\] and/or HIV serology positive with confirmatory quantitative HIV viral load) and started ART during acute infection (Fiebig stage I-V)
•7. Uninterrupted treatment with ART (no interruption of ART for ≥7 consecutive days or longer) since ART initiation, for ≥ 48 weeks.
•8. Currently on integrase inhibitor-based ART regimen (excluding long-acting injectable regimens) and no recent (≤8 weeks prior to screening) changes to ART regimen.
•a. There must be at least one documented plasma HIV RNA \<50 cps/mL after the last ART change prior to screening
+35 more criteria

Exclusion Criteria

•Participants who meet any of the following criteria will be excluded from the study:
•1. Weight \<50 kg or \> 115 kg
•2. Presence of HLA allele associated with viral control including HLA B\*57:01 or HLA B\*58:01 (based on archived data from RV254)
•3. Anyone with contraindication to intramuscular injections, placement of intravenous lines, and blood draws
•4. Acute or serious illness requiring systemic treatment and/or hospitalization within 90 days prior to entry.
•5. Any clinically significant acute or chronic medical condition, that in the opinion of the investigator would preclude participation including cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological disorders, that in the opinion of the investigator would preclude participation (e.g., history of seizure disorders, cardiovascular disease, bleeding/clotting disorder, autoimmune disease, malignancy, poorly controlled asthma, active tuberculosis or other systemic infections, etc.)
•1. Participants with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) including untreated syphilis, gonorrhea or chlamydia infection or temperature ≥38.0ºC within 24 hours prior to the first dose of IP will not enter baseline. Participant will be referred for treatment, and participant is eligible for repeat screening and potential study entry once treatment is successfully completed
•2. Major surgery (per the Investigator's judgment) within 12 weeks before screening or plan to have major surgery during the time of study participation
•• surgical procedures to be conducted under local or loco-regional anesthesia and not judged as major by the Investigator may participate.
•3. Current or history of an HIV-associated malignancy (including Kaposi's sarcoma), and any type of lymphoma, or virus-associated cancers
+33 more criteria

Locations (2)

Thai Red Cross AIDS Research Centre (TRCARC)

Pathum Wan, Bangkok, Thailand

The Faculty of Medicine, Chulalongkorn University/ King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, Thailand

Key Dates

Start Date

September 1, 2023

Primary Completion Date

July 1, 2025

Completion Date

July 1, 2025

Last Updated

May 3, 2024

Conditions

HIV-1-infection

Interventions

VRC07-523LS

BIOLOGICAL

PGDM1400LS

BIOLOGICAL

N-803

BIOLOGICAL

Ad26.Mos4.HIV

BIOLOGICAL

MVA-BN-HIV

BIOLOGICAL

A244d11 gp120

BIOLOGICAL

ALFQ

BIOLOGICAL

Antiretroviral Therapy (ART)

COMBINATION_PRODUCT

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

NCT07055451

HIV-1-infection

View study

RECRUITINGNA

Treatment Research Investigating Depression Effects on Neuroimmune Targets (TRIDENT)

NCT05136703

DepressionHIV-1-infection+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission

Inclusion Criteria

Exclusion Criteria

Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV

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