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ATI to Assess Immune Control of HIV
N/A
Waitlist Available
Research Sponsored by HIV Vaccine Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Immunology/Virology: HIV-1 infection, with reactive HIV-1 antibody and any Multispot or Geenius HIV-1/HIV-2 results, documented by the HVTN 704/HPTN 085 HIV diagnostic algorithm.
Hematology: Hemoglobin (Hgb) ≥ 10.0 g/dL for volunteers who were assigned female sex at birth, ≥ 11.0 g/dL for volunteers who were assigned male sex at birth.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured through participant's last visit on schedule 1 or 2, on average 3 months
Awards & highlights
Study Summary
This trial is evaluating whether VRC01 can help the body's immune system control HIV, even without HIV medication. Participants will stop taking their HIV medication and have their health monitored closely.
Who is the study for?
This trial is for adults who became HIV-positive during the HVTN 704/HPTN 085 study, have been on ART for at least a year, and meet specific health criteria like certain blood cell counts. They must not be pregnant or breastfeeding, agree to use effective contraception, and can't join other drug studies. People with unstable heart disease, recent infections or vaccinations, or those who've had certain treatments that affect the immune system can't participate.Check my eligibility
What is being tested?
The trial is testing if stopping HIV medication (ART) temporarily (Analytical Treatment Interruption) allows the immune system to control HIV without drugs in participants previously given VRC01 antibody or placebo. It will monitor how well their bodies handle HIV after stopping ART and track any changes in viral levels and immune response.See study design
What are the potential side effects?
Since this trial involves stopping ART rather than taking new medications, side effects are related to potential increases in HIV levels such as flu-like symptoms, fatigue, and possible worsening of existing conditions due to a temporary decrease in immune function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am HIV positive, confirmed by specific tests.
Select...
My hemoglobin level is at least 10.0 g/dL if I was assigned female at birth, or at least 11.0 g/dL if I was assigned male.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured through participant's last visit on schedule 1 or 2, on average 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured through participant's last visit on schedule 1 or 2, on average 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who discontinue ATI
Percentage of participants who experience adverse events (AEs
Percentage of participants who experience serious adverse events (SAEs)
+3 moreSecondary outcome measures
Frequency of CD4+ T cells carrying intact and/or total pro-viral HIV DNA, replication competent virus, and/or cell-associated HIV RNA
Frequency of T- and B-cell activation and exhaustion markers
Frequency of dendritic cell activation and maturation markers
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Analytical Treatment InterruptionExperimental Treatment1 Intervention
Participants who received VRC01 or placebo and got HIV while enrolled in HVTN 704/HPTN 085 (NCT02716675).
Find a Location
Who is running the clinical trial?
HIV Vaccine Trials NetworkLead Sponsor
39 Previous Clinical Trials
10,739 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,481,114 Total Patients Enrolled
HIV Prevention Trials NetworkNETWORK
30 Previous Clinical Trials
568,686 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently pregnant or breastfeeding.I have no psychiatric conditions that would stop me from following the study rules.I am willing and able to change my HIV medication before stopping it for a while.I haven't taken strong immune-weakening medicines in the last 6 months, except for some allowed minor treatments.I can visit the study center and follow the study schedule.I have never had an AIDS-defining illness.I am willing to use condoms for all sexual activities until my viral load is confirmed to be low again.I had cancer removed and my doctor believes it's unlikely to come back during the study.I have a health condition that could affect my participation in the study.I do not have serious heart or stroke-related conditions.I have an untreated or partially treated STD (syphilis, gonorrhea, or chlamydia).You have a medical or mental health condition that could get worse by participating in the study, including different types of viral infections and restarting treatment.I am willing to restart my ART treatment when needed.I have been on HIV medication for over a year with short breaks allowed.I am HIV positive, confirmed by specific tests.I have received non-live vaccines like tetanus or hepatitis within the last 14 days.You have an autoimmune disease, except if it is mild, stable, and doesn't require constant immunosuppressive medication. The study doctor will decide if your autoimmune disease is mild enough to participate in the trial.I do not have active tuberculosis, or if I have latent tuberculosis, I've been treated for at least a month.My hemoglobin level is at least 10.0 g/dL if I was assigned female at birth, or at least 11.0 g/dL if I was assigned male.I have not received any blood products in the last 4 months.My HIV-1 levels have been undetectable for over 9 months.I am not pregnant or cannot become pregnant due to menopause or surgery.I have received a COVID-19 vaccine within the last 4 weeks.I have not received any live vaccines in the last 30 days.I started HIV treatment within 28 weeks of my diagnosis.You give permission for the study staff to talk to your primary doctor about your medical history related to HIV and the study.You have a neurological disease, like HIV dementia, that would prevent you from participating in the study according to the investigator's judgment.You cannot have taken any experimental drugs (except vaccines) within 30 days before stopping your current treatment plan.You contracted HIV-1 within 8 weeks after your last HVTN 704/HPTN 085 infusion.I am willing to pause my ART treatment for up to 24 weeks.My doctor believes a different HIV treatment could work if my current one fails.
Research Study Groups:
This trial has the following groups:- Group 1: Analytical Treatment Interruption
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any slots for this clinical research still available to participants?
"Affirmative. Records published on clinicaltrials.gov demonstrate that this trial, which was first posted online in late August 2022, is currently enrolling participants. A total of 30 individuals are required to be recruited from 4 distinct treatment centres."
Answered by AI
At how many sites is this clinical experiment being conducted?
"The BWH VCRS in Boston, Philadelphia HIV Therapeutics and Prevention CRS in Pennsylvania, and UCLA Vine Street Clinic CRS in California are the primary medical institutions involved with this clinical trial. Additionally, 4 other locations have also been recruited to participate."
Answered by AI
Could you explain the main aims of this clinical trial?
"This medical trial's primary goal is to measure the rate of participants who end their involvement early over a 3-month span. Additionally, investigators will also assess response rates from HIV-specific CD4+ and CD8+ T-cells through flow cytometry, magnitude of neutralizing antibodies (nAb) responses against autologous and heterologous HIV isolates via TZM-bl neutralization assay, as well as magnitude of HIV-specific CD4+ and CD8+ cells with flow cytometry."
Answered by AI
What is the extent of enrollment for this clinical trial?
"An aggregate of 30 qualified individuals are necessary for this trial. Locations where participants can partake include Brigham and Women's Hospital Vaccine CRS (BWH VCRS) in Boston, Massachusetts as well as Philadelphia HIV Therapeutics and Prevention CRS in Pennsylvania."
Answered by AI
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