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bNAbs + N-803 for HIV/AIDS
Study Summary
This trial will study the safety and effectiveness of two long-acting broadly neutralizing antibodies, plus an IL-15 superagonist complex, in treating adults with HIV who are already on antiretroviral therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 1 trial • 6 Patients • NCT04250636Trial Design
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Who is running the clinical trial?
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- I started antiretroviral therapy soon after my infection was diagnosed.I have a history of heart disease related to artery blockage.I have hepatitis B or C.I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.I am on HIV treatment with undetectable virus levels for at least 48 weeks.I have not had an AIDS-defining illness in the last 3 years.My HIV is resistant to drugs in two or more classes.I don't have any major health issues that would stop me from joining.I haven't taken steroids, immunosuppressants, or major cancer treatments in the last 6 months.I have had cancer treatment or surgery in the last 3 years, or expect to in the next year.I am between 18 and 70 years old.I have never had Progressive Multifocal Leukoencephalopathy (PML).I am willing to change my HIV medication to an integrase inhibitor for at least 4 weeks before stopping ART.I am HIV positive.I agree to use protection during sex while on treatment breaks and until my virus levels are low again.I have not received cabotegravir or rilpivirine injections in the last 2 years.
- Group 1: 3BNC117-LS + 10-1074-LS + N-803
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Could you provide information about the safety of 3BNC117-LS for human use?
"Our assessment of 3BNC117-LS's safety on a scale from 1 to 3 is low at 1, due to the limited clinical evidence supporting this drug's efficacy and security."
Are there any open opportunities for participants in this experiment?
"According to the clinicaltrials.gov platform, this medical research is currently recruiting patients with its initial post dated December 1st 2022 and a recent edit on November 22nd 2022."
What is the current participant capacity for this research trial?
"Affirmative. According to information posted on clinicaltrials.gov, this research project is recruiting participants at present time; it was first made available for application on December 1st 2022 and has been recently updated on November 22nd 2022 with the goal of enrolling 36 individuals from 3 different locations."
Does this research involve participants older than 30 years of age?
"According to the trial's requirements, only patients between 18 and 70 years of age are eligible. Separately, 149 trials have been created for minors while 467 exist specifically for elderly individuals."
What purpose does this clinical investigation seek to achieve?
"In this 72 week trial, the primary outcome is to identify participants who have not restarted anti-retroviral therapy (ART) by weeks 60 and 72. Secondary assessments include quantifying Treatment-related Grade 2 adverse events, calculating Time from ART withdrawal to re-initiating ART, and measuring Changes in HIV-1 specific T Cell immune responses with ELISPOT at different points throughout the study."
Is there any possibility for me to partake in this investigation?
"This clinical trial is enrolling 36 adults (18 - 70 years old) with acquired immunodeficiency syndrome. Eligibility criteria include both genders, a confirmed HIV-1 infection and plasma levels of < 50 copies/ml, CD4+ T cell counts > 450 cells/mcL, CD4+ T cell % ≥ 15%, and a nadir of ≥ 200 cells/mcL. Additionally, participants that can become pregnant must have negative pregnancy tests at screening and within 48 hours prior to day 0 as well as use two forms of contraception for 12 months after the last dose of investigational product. For those engaging in"
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