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Monoclonal Antibodies + ART for HIV Infection

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from step 2 entry through 24 weeks after art interruption

Awards & highlights

Study Summary

This trial studies if giving ART + HIV-specific antibodies can help suppress HIV in adults with acute HIV infection.

Who is the study for?

Adults aged 18-70 with recent acute HIV infection who haven't started antiretroviral therapy (ART) can join. They must have certain blood counts, agree to use barrier contraception or abstain from sex, and not be pregnant. People with severe allergies, active Hepatitis B/C, drug/alcohol dependence, or other conditions that could interfere with the trial cannot participate.Check my eligibility

What is being tested?

The study is testing if adding combination HIV-specific broadly neutralizing antibodies (bNAbs) VRC07-523LS and PGT121.414.LS to standard ART in newly infected individuals can safely delay HIV rebound after treatment pause and reduce viral reservoirs compared to placebo plus ART.See study design

What are the potential side effects?

Potential side effects of bNAbs may include allergic reactions like hives or swelling, infusion-related reactions during administration of the antibodies, fatigue, headache, and possible increased risk of infections due to immune system changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from step 2 entry through 24 weeks after art interruption

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from step 2 entry through 24 weeks after art interruption

This trial's timeline: 3 weeks for screening, Varies for treatment, and from step 2 entry through 24 weeks after art interruption for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Grade ≥2 AE or SAE that are possibly, probably, or definitely related to the study bNAbs during Step 1

Time from ART discontinuation to HIV-1 RNA ≥1,000 copies/mL for 4 consecutive weeks during Step 2

Secondary outcome measures

Area under the curve (AUC) of VRC07-523LS and PGT121.414.LS when administered together

Change in CD4+/CD8+ T-cell counts during Step 2

Clearance (Cl/F) of VRC07-523LS and PGT121.414.LS when administered together

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 1: VRC07-523LS + PGT121.414.LS + ARTExperimental Treatment3 Interventions

Group II: Arm 2: Placebo + ARTPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

VRC07-523LS

2019

Completed Phase 1

~310

PGT121.414.LS

2020

Completed Phase 1

~40

ART

2008

Completed Phase 4

~7770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,420 Total Patients Enrolled

Trevor Crowell, MD, PhDStudy ChairU.S. Military HIV Research Program CTU

2 Previous Clinical Trials

158 Total Patients Enrolled

Media Library

ART Clinical Trial Eligibility Overview. Trial Name: NCT05719441 — Phase 2

HIV Infection Research Study Groups: Arm 2: Placebo + ART, Arm 1: VRC07-523LS + PGT121.414.LS + ART

HIV Infection Clinical Trial 2023: ART Highlights & Side Effects. Trial Name: NCT05719441 — Phase 2

ART 2023 Treatment Timeline for Medical Study. Trial Name: NCT05719441 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research recruiting geriatric participants?

"This trial only admits applicants between 18 and 70 years old. However, there are 290 studies available to minors, while those above the age of 65 have 893 trials at their disposal."

Answered by AI

Is access to this experiment available for participants at present?

"Clinicaltrials.gov reveals that, as of January 30th 2023, this clinical trial is no longer recruiting participants. The initial posting was made on March 6th 2023 and the final update occurred a few months ago. Fortunately, 1161 other trials are still open for enrollment at this time."

Answered by AI

How many facilities are hosting this clinical investigation?

"Currently, 32 sites are enrolling patients into this study. Major cities in California such as Los Angeles, San Diego and San Francisco have trial centers available. To make participation more comfortable, please select the location closest to you to minimize travel needs."

Answered by AI

What can be said about the security of Arm 1: VRC07-523LS + PGT121.414.LS + ART for patients?

"Our experts at Power estimate that the safety of Arm 1: VRC07-523LS + PGT121.414.LS + ART is a 2, since there has been clinical evidence to suggest its security but no trials showing its efficacy yet."

Answered by AI

May I be considered as a participant in this experiment?

"This clinical trial has capacity for 48 individuals aged 18 to 70 who have been recently diagnosed with acute HIV infection, and must meet a series of additional criteria such as detectable HIV-1 RNA within 28 days prior to study entry and nonreactive HIV-1 antibody within 7 days prior. Furthermore, they need an absolute neutrophil count larger than 1,000/mm3; platelet count greater than 100,000/mm3; estimated glomerular filtration rate above 50 mL/min/1.73m2; ALT (SGPT) below 2.5 x ULN; AST (SGOT) lower"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission

2024. "A Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined With ART Initiation During Acute HIV Infection to Induce HIV Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05719441.