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Monoclonal Antibodies + ART for HIV Infection
Phase 2
Recruiting
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 up to 5 years
Awards & highlights
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.
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.
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 ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
PGT121.414.LS
2020
Completed Phase 1
~40
VRC07-523LS
2019
Completed Phase 2
~390
ART
2008
Completed Phase 4
~7770
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,394 Total Patients Enrolled
Trevor Crowell, MD, PhDStudy ChairU.S. Military HIV Research Program CTU
2 Previous Clinical Trials
158 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received immunoglobulin therapy before.I have received a human or humanized monoclonal antibody treatment, not for COVID-19.I have restarted antiretroviral therapy.I haven't taken any immune system altering drugs in the last 6 months.I have received all the required doses of the study treatment.I have used antiretroviral therapy within the last 60 days.I have a serious health condition that is new, ongoing, or has recently worsened.I am between 18 and 70 years old.I haven't taken any medications that aren't allowed with bictegravir, emtricitabine, and tenofovir alafenamide in the last week.I have received specific medications after my initial trial entry.I was in the late stage of my infection when I joined the study.I am willing and able to attend all study appointments.I am not willing or able to restart my ART medication after being advised to.I am willing and able to start antiretroviral therapy at enrollment.I have a history of or currently have heart or blood vessel disease.I have or recently had cancer that needed chemo or surgery, not related to HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2: Placebo + ART
- Group 2: Arm 1: VRC07-523LS + PGT121.414.LS + ART
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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