HIV InfectionsPhase 1RESISTNCT03485963
HIV-1 Specific T -Cells (HST-NEETs) for HIV-Infected Individuals
A Phase 1 study testing HST-NEETs in people with HIV Infections, run by Catherine Bollard at 3 sites in United States.
Trial summary
This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- HST-NEETs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2019to 21 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient Inclusion Criteria for cell procurement and cell infusion:
- ≥ 18 years and < 65 years of age
- Confirmation of HIV-1 infection
- any licensed ELISA test kit which is confirmed by Western blot or Multispot HIV-1/HIV-2 assay prior to screening. HIV culture, HIV antigen, plasma HIV RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- On potent antiretroviral therapy, defined as at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor without interruption (Interruption is defined as missing doses by self report for no more than two (2) consecutive days or more than four (4) cumulative days) in the 12 weeks prior to cell procurement for HST NEETs manufacturing. Other potent fully suppressive antiretroviral combinations will be considered on a case- by-case basis. Prior changes in or elimination of medications for easier dosing schedule, intolerance, toxicity, or other reasons are permitted if an alternative suppressive regimen was maintained under the compliance criteria above.
- Stable ART regimen for minimum of 12 weeks with no detectable HIV RNA concentrations as defined above. Participants may have had one or more changes in their ART regimen during the 12 week for tolerance, or dosing simplification.
Show all 19Show fewer
- Ability and willingness of participant to continue and be compliant with cART throughout the study.
- Plasma HIV-1 RNA below detectable limit by conventional CLIA approved assays (<50 copies/mL) for ≥ 1 year. A single unconfirmed plasma HIV RNA > limit of detection but < 1000 c/mL is allowed within the 12 months prior to screening/cell donation but none in the preceding 6 months, is permitted provided that a repeat RNA was < 20.
- Plasma HIV-1 RNA < 50 copies/mL at screening.
- CD4+ cell count > 350 cells/mm3 at screening.
- Karnofsky score of ≥ 50%
- No active HCV infection (measureable HCV RNA) within 90 days of cell procurement.
- No active HBV infection (measureable HBV DNA or HBVsAg+) within 90 days of cell procurement.
- All female participants participating in sexual activity that could lead to pregnancy must agree to use at least two of the following reliable methods of birth control (at least one of which is a barrier method) for at least 21 days prior to study entry, continuing and until 12 weeks after the last dose of the study product: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, Intrauterine Device, hormone-based contraceptive, tubal ligation, NuvaRing.
- All male participants participating in sexual activity that could lead to pregnancy must agree to use condoms for at least 21 days prior to study entry, continuing and until 12 weeks after the last dose of the study product.
- Ability and willingness of subject to give written informed consent.
- Ability and willingness to provide adequate locator information and contact information for at least 2 adults who can reach the participant within 24 hours
- Ability and willingness to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
- Adequate vascular access (peripheral and central) for HST-NEET infusion.
Who cannot join
- Prior use of any HIV immunotherapy or vaccine within 12 months prior to Screening.
- Use of any of the following within 90 days prior to entry: immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, IFN, interleukin-2 (IL-2), Coumadin, warfarin, or other Coumadin derivative anticoagulants.
- Patients on a CCR5 inhibitor or an entry inhibitor are not eligible for participation in the study
- Received any infusion blood product, immune globulin, or hematopoietic growth factors within 90 days prior to study entry.
- History of malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the performance site PIs.
- Any active malignancy that may require chemotherapy or radiation therapy.
- Any licensed or experimental non-HIV vaccination (e.g., hepatitis B, influenza, pneumococcal polysaccharide) within 4 weeks prior to study entry.
- Inability to comply with study requirements, which could impact study integrity and/or safety.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Whitman Walker Health Research Department (Wwh)
Washington D.C., District of Columbia, 20005
Children's National Hospital
Washington D.C., District of Columbia, 20010
Children's National Medical Center and WHITMAN WALKER HEALTH RESEARCH DEPARTMENT (WWH)
Washington D.C., District of Columbia, 20010
About this study
Official title: A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection
This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).
Read the detailed description
Treatment Description: This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on ART. Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. Those meeting study eligibility and with successful production of HST-NEETs will then enter Step 2 where patients have the OPTION of being enrolled on a separate GWU Protocol 04216 to obtain a pre- and post- HST-NEET treatment leukapheresis procedure to measure the frequency of HIV-1 infection of resting CD4+ T cells using the viral outgrowth assay. All participants will then receive (within 30 days of the leukapheresis procedure if applicable) the same treatment and dose (2x107/m2) of HST-NEETs in Step 2. 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.
Sample Size and Study Duration: Up to 12 HIV-infected individuals followed for 48 weeks.
Accrual Objective: The total sample size is 12 participants. Participants will be followed for 48 weeks. Because the focus of the study is on safety and potential adverse events are most likely to occur within 28 days of administration, accrual will be staggered such that enrollment and treatment administration will include a maximum of 1 participant per week. Participants who do not receive study treatment will be replaced. In addition, any participant who is not administered the full study treatment infusion, or discontinues the study prior to day 28 without having met the primary safety endpoint will be replaced until the target enrollment of participants is met.
- Conditions
- HIV Infections
- Being tested
- HST-NEETs
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HST-NEETsBiological
The primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection.
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose HIV-1 specific T-cells (HST-NEETs) | Experimental | 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. Receives: Biological: HST-NEETs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Product-Emergent Adverse Events
Occurrence of any ≥ Grade 3 AE including signs/symptoms, lab toxicities, and/or clinical events, that is possibly, probably or definitely related to study treatment any time from the first day of study treatment until 28 days after the last infusion. Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study. Relationship to study treatment will be judged by the protocol team. If any Grade 4 or 5 Serious Adverse Events occur, this will trigger an immediate pause in the protocol while the relationship to the T cell therapeutic is evaluated. If the attribution is deemed probably or definitely related to the study agent, the protocol will stop.
Measured: from the first day of study treatment until 28 days after the last infusion.
Secondary outcomes (1)
HST-NEETS responses
Determine the number of patients who respond to HST_NEETS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start21 Mar 2019
- Primary completion15 Sep 2021
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catherine Bollard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Catherine Bollard, Children's National Research Institute
- Investigators
- Michael Keller, MD, Principal investigator, CNMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485963
- Sponsor's protocol ID
- Pro00009968
- Acronym
- RESIST
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2018
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Immunologic, and Virologic RESponses of HIV-Specific T-cells With Non-escaped Epitope Targeting (HST-NEETs) as a Therapeutic Strategy in HIV-Infected Individuals on Antiretroviral Therapy During Acute And Chronic Infection
- ClinicalTrials.gov ID
- NCT03485963
- Acronym / sponsor ID
- RESIST / Pro00009968
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Catherine BollardUniversity, hospital or other
- Study start
- 21 Mar 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on antiretroviral therapy (ART).
Detailed description
Treatment Description: This is a phase I, multi-site, study of the safety, immunologic and virologic responses of ex vivo expanded HIV-1 multi-antigen specific T-cell therapy (HST-NEET) as a therapeutic strategy in HIV-infected individuals suppressed on ART. Patients will be screened for eligibility in Step 1 and undergo a blood draw of 100-120mL to allow production of autologous HST-NEETS. Those meeting study eligibility and with successful production of HST-NEETs will then enter Step 2 where patients have the OPTION of being enrolled on a separate GWU Protocol 04216 to obtain a pre- and post- HST-NEET treatment leukapheresis procedure to measure the frequency of HIV-1 infection of resting CD4+ T cells using the viral outgrowth assay. All participants will then receive (within 30 days of the leukapheresis procedure if applicable) the same treatment and dose (2x107/m2) of HST-NEETs in Step 2. 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.
Sample Size and Study Duration: Up to 12 HIV-infected individuals followed for 48 weeks.
Accrual Objective: The total sample size is 12 participants. Participants will be followed for 48 weeks. Because the focus of the study is on safety and potential adverse events are most likely to occur within 28 days of administration, accrual will be staggered such that enrollment and treatment administration will include a maximum of 1 participant per week. Participants who do not receive study treatment will be replaced. In addition, any participant who is not administered the full study treatment infusion, or discontinues the study prior to day 28 without having met the primary safety endpoint will be replaced until the target enrollment of participants is met.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fixed dose HIV-1 specific T-cells (HST-NEETs) | Experimental | Biological: HST-NEETsPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- ≥ 18 years and < 65 years of age
- Confirmation of HIV-1 infection
- On potent antiretroviral therapy, defined as at least 2 nucleoside/nucleotide reverse transcriptase inhibitors plus a non-nucleoside reverse transcriptase inhibitor, integrase inhibitor, or a protease inhibitor without interruption (Interruption is defined as missing doses by self report for no more than two (2) consecutive days or more than four (4) cumulative days) in the 12 weeks prior to cell procurement for HST NEETs manufacturing. Other potent fully suppressive antiretroviral combinations will be considered on a case- by-case basis. Prior changes in or elimination of medications for easier dosing schedule, intolerance, toxicity, or other reasons are permitted if an alternative suppressive regimen was maintained under the compliance criteria above.
- Stable ART regimen for minimum of 12 weeks with no detectable HIV RNA concentrations as defined above. Participants may have had one or more changes in their ART regimen during the 12 week for tolerance, or dosing simplification.
- Ability and willingness of participant to continue and be compliant with cART throughout the study.
Key exclusion criteria (8 listed)
- Prior use of any HIV immunotherapy or vaccine within 12 months prior to Screening.
- Use of any of the following within 90 days prior to entry: immunomodulatory, cytokine, or growth stimulating factors such as systemic corticosteroids, cyclosporine, methotrexate, azathioprine, anti-CD25 antibody, IFN, interleukin-2 (IL-2), Coumadin, warfarin, or other Coumadin derivative anticoagulants.
- Patients on a CCR5 inhibitor or an entry inhibitor are not eligible for participation in the study
- Received any infusion blood product, immune globulin, or hematopoietic growth factors within 90 days prior to study entry.
- History of malignancy, immunodeficiency other than HIV, or any other condition that would make the subject unsuitable for the study in the opinion of the performance site PIs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HST-NEETsThe primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection. | Biological | Fixed dose HIV-1 specific T-cells (HST-NEETs) |
Primary outcome
Incidence of Product-Emergent Adverse Events
Time frame: from the first day of study treatment until 28 days after the last infusion.
Occurrence of any ≥ Grade 3 AE including signs/symptoms, lab toxicities, and/or clinical events, that is possibly, probably or definitely related to study treatment any time from the first day of study treatment until 28 days after the last infusion. Safety data will include local and systemic signs and symptoms, laboratory measures of safety/toxicity, and all adverse and serious adverse events. Safety data will be routinely collected throughout the duration of the study. Relationship to study treatment will be judged by the protocol team. If any Grade 4 or 5 Serious Adverse Events occur, this will trigger an immediate pause in the protocol while the relationship to the T cell therapeutic is evaluated. If the attribution is deemed probably or definitely related to the study agent, the protocol will stop.
1 secondary outcome
HST-NEETS responses
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Keller, MD principal investigator
CNMC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HST-NEETs in people with HIV Infections, run by Catherine Bollard at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Product-Emergent Adverse Events (time frame: from the first day of study treatment until 28 days after the last infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.