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CAR T-cell Therapy

HST-NEETs for HIV (RESIST Trial)

Q: Is the enrollment period for this research still open?

According to the clinicaltrials.gov website, this medical trial is not presently searching for participants as it was last updated on February 22nd 2022. However, there are 1181 other active studies that have open recruitment at this time.

Q: Am I eligible to be a participant in this medical experiment?

This clinical trial is currently accepting seven individuals with <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a> infections who are aged between 18 and 65. In order to be eligible, they must also have been consistently taking potent antiretroviral therapy for the last 12 weeks without interruption or changes in medication, possess a Karnofsky score of at least 50%, present no detectable levels of HIV RNA concentrations as confirmed by an ELISA kit (or equivalent), and agree to remain compliant with their cART throughout the study's duration.

Q: Has the FDA sanctioned HST-NEETs for therapeutic use?

Our team at Power gave HST-NEETs a score of 1 due to the limited evidence for its efficacy and safety, as this is still in Phase 1.

Q: Does this research permit the enrollment of elderly participants?

This clinical trial is for patients aged 18 to 65. For those outside that age range, there are 293 trials open to minors and 900 studies available for seniors.

Phase 1

Waitlist Available

Led By Michael Keller, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

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

Must have

Karnofsky score of ≥ 50%

≥ 18 years and < 65 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

RESIST Trial Summary

This trial is testing a new HIV treatment that uses the body's own T-cells. The aim is to see if it is safe and if it can help people with HIV who are already on treatment.

Who is the study for?

This trial is for HIV-infected adults aged 18-65 with undetectable viral loads on ART for at least a year, CD4+ counts over 350, and no active hepatitis. Participants must be willing to continue ART, use contraception, and have good vascular access. Excluded are those with recent cancer treatments or immunotherapies, certain medication use within the last 90 days, or any condition that may interfere with the study.Check my eligibility

What is being tested?

The trial tests HST-NEETs (HIV-specific T-cells) in individuals who are HIV-positive but have controlled the virus using antiretroviral therapy (ART). It's a phase I study focusing on safety and how well these cells can boost immune response against HIV.See study design

What are the potential side effects?

As this is an early-phase trial primarily assessing safety of HST-NEETs cell therapy in humans, specific side effects aren't listed but may include typical reactions related to immune therapies such as infusion-related symptoms or autoimmune-like conditions.

RESIST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am able to live with some assistance.

Select...

I am between 18 and 64 years old.

Select...

I have good veins for receiving infusion treatments.

RESIST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of Product-Emergent Adverse Events

Secondary outcome measures

HST-NEETS responses

RESIST Trial Design

1Treatment groups

Experimental Treatment

Group I: Fixed dose HIV-1 specific T-cells (HST-NEETs)Experimental Treatment1 Intervention

Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. patients will receive a fixed dose of 2x10e7/m2. For the first 3 recipients, the infusions will occur 4 weeks apart. If no adverse reactions occur that are attributable to the HST-NEETs, the recipients thereafter will receive the two infusions separated by 2 weeks.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Catherine BollardLead Sponsor

13 Previous Clinical Trials

324 Total Patients Enrolled

Michael Keller, MDPrincipal InvestigatorCNMC

3 Previous Clinical Trials

116 Total Patients Enrolled

Media Library

HST-NEETs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03485963 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: Fixed dose HIV-1 specific T-cells (HST-NEETs)

Human Immunodeficiency Virus Infection Clinical Trial 2023: HST-NEETs Highlights & Side Effects. Trial Name: NCT03485963 — Phase 1

HST-NEETs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03485963 — Phase 1

Frequently Asked Questions

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

Is the enrollment period for this research still open?

"According to the clinicaltrials.gov website, this medical trial is not presently searching for participants as it was last updated on February 22nd 2022. However, there are 1181 other active studies that have open recruitment at this time."

Answered by AI

Am I eligible to be a participant in this medical experiment?

"This clinical trial is currently accepting seven individuals with HIV infections who are aged between 18 and 65. In order to be eligible, they must also have been consistently taking potent antiretroviral therapy for the last 12 weeks without interruption or changes in medication, possess a Karnofsky score of at least 50%, present no detectable levels of HIV RNA concentrations as confirmed by an ELISA kit (or equivalent), and agree to remain compliant with their cART throughout the study's duration."

Answered by AI

Has the FDA sanctioned HST-NEETs for therapeutic use?

"Our team at Power gave HST-NEETs a score of 1 due to the limited evidence for its efficacy and safety, as this is still in Phase 1."

Answered by AI

Does this research permit the enrollment of elderly participants?

"This clinical trial is for patients aged 18 to 65. For those outside that age range, there are 293 trials open to minors and 900 studies available for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals

Catherine Bollard 2019. "HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03485963.

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