HIVNCT05540964
An Antiretroviral Treatment Interruption (ATI) Study to Evaluate the Impact of Genetically Modified Autologous Cells (AGT103-T) to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy
An observational study of HIV, run by American Gene Technologies International Inc. at 2 sites in United States.
Trial summary
To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV
- What is being tested?
- Antiretroviral Therapy Interruption(ATI)
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Jul 2022to 19 Jul 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject who were infused with the investigational product AGT103-T in the AGT168 clinical trial
Who may be able to join
- Successful engraftment of AGT103-T with at least 30 days post-infusion safety monitoring during the AGT-HC-168 Parent Study.
- Note: Successful engraftment is defined as detectable levels of AGT103-T cells bearing the AGT103 lentivirus vector.
- HIV <50 copies of viral RNA/mL plasma on stable ART.
- Continuation on the same ART regimen during the AGT-HC-168 Parent Study unless change in treatment with ART regimen is medically indicated.
- CD4 T cell count >400 cells/mm3.
- Ability to understand the study and willingness to comply with study-required procedures and visits.
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- Written informed consent signed and dated by the study participant.
- A negative pregnancy test for females of childbearing potential. A female participant is considered to be of childbearing potential if she is menstruating, has an intact uterus and at least 1 ovary, and is less than 2 years postmenopausal.
- Unless medically prescribed, a negative drug test for amphetamines; barbiturates; benzodiazepines; cocaine; methadone (Dolophine®); opiates (codeine, morphine only); phencyclidine (PCP); propoxyphene.
- Female participants of childbearing potential and male participants who are sexually active with a partner of childbearing potential must agree to use an adequate method of contraception at screening and throughout trial participation.
- Female and male participants who are sexually active with a partner must agree to abstain from sexual activity or use an adequate method of protection (e.g., condoms) at screening and throughout trial participation.
- Agree to not receive immunosuppressive and/or investigational therapies during the study.
- Note: Prohibited immunosuppressive medications do not include corticosteroid nasal spray or inhaler; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids given for non-chronic conditions.
- Has adequate organ function as indicated by the following laboratory values:
- Hematocrit ≥33% or hemoglobin ≥13 g/dL (males) and ≥12 g/dL (females)
- Platelet count ≥150,000/mm3
- Absolute neutrophil count ≥1,500/mm3
- Serum creatinine ≤1.3 times ULN or calculated creatinine clearance (for those with creatinine >1.3 ULN) ≥60 mL/min
- Prothrombin Time or INR ≤ 1.5 times ULN
- Total bilirubin <1.5 times the ULN range. If total bilirubin is elevated, direct bilirubin must be < 2 times the ULN range, except in participants with Gilbert's Syndrome who must have serum bilirubin <3.0 times ULN (NOTE: If participant is on an atazanavir containing therapy then a direct bilirubin should be measured instead of the total bilirubin and must be ≤ 1.0 mg/dL. Also, asymptomatic elevations due to ART medications are not exclusionary when, in the opinion of the Investigator, the abnormalities are not attributable to intrinsic hepatic disease.
- Amylase < 3.0 times ULN at the time of screening
- AST (SGOT) and ALT (SGPT): ≤ 3.0 times ULN
Who cannot join
- Any Grade 3 or higher drug product-related AE in the AGT-HC-168 Parent Study (participant may be enrolled once AE resolved).
- Any change in health status that would exclude enrollment in the AGT-HC-168 Parent Study.
- Active viral hepatitis B or hepatitis C infection. A complete hepatitis B virus (HBV) screen (B core antibody, HBV surface antibody, and HBV surface antigen testing) must be completed. Viral load testing will be used in questionable cases, per the discretion of the Investigator.
- The results for hepatitis B may be positive for surface antibodies against HBV but must be negative for circulating HBV surface antigen to confirm the absence of active infection.
- The results for hepatitis C virus (HCV) may be positive for antibodies against HCV but must be negative for HCV viral RNA in blood to confirm the absence of active infection.
- History of or current cancer or malignancy, with the exception of successfully treated basal cell carcinoma of the skin.
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- Current diagnosis of New York Heart Association Grade 3 or 4 congestive heart failure, uncontrolled angina, or arrhythmias.
- Any clinically significant renal, hepatic, or pulmonary disease.
- Is being treated for culture-confirmed bacteremia or had culture-confirmed bacteremia within 1 month prior to screening.
- Has signs or symptoms of acute infectious disease.
- Significant laboratory values and/or chronic medical condition that in the opinion of the Principal Investigator could impact trial participation.
- Currently pregnant or breast-feeding.
- Unwilling to use acceptable methods of birth control from the time of study entry to 1 month after restart of ART if sexually active with opposite sex. The following are acceptable methods of birth control: condoms (male or female) with or without a spermicidal agent, intrauterine device, diaphragm or cervical cap with spermicide, or hormonal-based contraception.
- Active alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements.
- Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to screening.
- Subject is unwilling to agree to practice safe sex or share needles.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Georgetown University
Washington D.C., District of Columbia, 20007
Washington Health Institute
Washington D.C., District of Columbia, 20017
About this study
Official title: An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact and Durability of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy(ART) in Participants With Human Immunodeficiency Virus(HIV) Previously Treated With AGT103-T
To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.
Read the detailed description
Study subjects who have been infused with AGT103-T in a prior trial (AGT-HC-168) will be invited to stop their antiretroviral therapy in two phases. The first antiretroviral interruption will be closely monitored and if at any point study termination criteria are met, the study participant will be placed back on antiretroviral therapy. The second antiretroviral therapy will be instituted once the inclusion criteria are met. The aim of two antiretroviral interruptions is to allow for adequate sensitization of the cells and expansion of the pool of infused gene-modified cells. The two-phased ATI allows for a more robust suppression of HIV in study participants. Participants are monitored closely to determine if the autologous T cells with which they were previously infused, modify the kinetics of HIV rebound. The study participant will be closely monitored for the recurrence of HIV viremia and a decrease in their CD4 lymphocyte number.
- Conditions
- HIV
- Being tested
- Antiretroviral Therapy Interruption(ATI)
- Keywords
- Gene Therapy, Genetically modified CD4 T cells, Antiretroviral therapy interruption, Lentivirus vector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antiretroviral Therapy Interruption(ATI)Other
Study participant that were previously infused with autologous genetically modified cell product will be taken off ART and followed closely by monitoring HIV rebound.
| Study group | Role | What they receive |
|---|---|---|
| Single group | Study participants will be taken off antiretroviral therapy and blood samples will be collected during each clinic visit. Receives: Other: Antiretroviral Therapy Interruption(ATI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV kinetics
Observe for changes in the HIV viral load.
Measured: 3 Years
CD T cell changes
Observe the changes in the CD4 T cells and CD8 T cells count following antiretroviral treatment interruption(ATI)
Measured: 3year
Secondary outcomes (2)
Assess the durability of AGT103-T gene-modified cells during and after ATI
Measure the AGT103-T gene-modified cell during and after ATI
Measured: 3 Year
CD T cells changes
Measure changes in frequency of Gag-specific CD4 and CD8 T cells following ATI
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start19 Jul 2022
- Primary completion19 Jul 2025 (estimated)
- Study completion19 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Gene Technologies International Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540964
- Sponsor's protocol ID
- AGT-HC-169
- Status last verified
- Nov 2022
- First submitted
- 8 Sep 2022
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jain A, Liou ML, Xiao L, Canepa GE. Impact of AGT103-T cell and gene therapy on intact HIV proviral reservoirs. AIDS. 2026 Jul 1;40(7):880-884. doi: 10.1097/QAD.0000000000004459. Epub 2026 Feb 11.
PubMed 41670418
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact and Durability of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy(ART) in Participants With Human Immunodeficiency Virus(HIV) Previously Treated With AGT103-T
- ClinicalTrials.gov ID
- NCT05540964
- Acronym / sponsor ID
- AGT-HC-169
- Conditions
- HIV
- Keywords
- Gene Therapy, Genetically modified CD4 T cells, Antiretroviral therapy interruption, Lentivirus vector
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- American Gene Technologies International Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Jul 2022 (actual)
- Primary completion
- 19 Jul 2025 (estimated)
- Study completion
- 19 Jul 2025 (estimated)
- First posted
- 15 Sep 2022 (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.
To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.
Detailed description
Study subjects who have been infused with AGT103-T in a prior trial (AGT-HC-168) will be invited to stop their antiretroviral therapy in two phases. The first antiretroviral interruption will be closely monitored and if at any point study termination criteria are met, the study participant will be placed back on antiretroviral therapy. The second antiretroviral therapy will be instituted once the inclusion criteria are met. The aim of two antiretroviral interruptions is to allow for adequate sensitization of the cells and expansion of the pool of infused gene-modified cells. The two-phased ATI allows for a more robust suppression of HIV in study participants. Participants are monitored closely to determine if the autologous T cells with which they were previously infused, modify the kinetics of HIV rebound. The study participant will be closely monitored for the recurrence of HIV viremia and a decrease in their CD4 lymphocyte number.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: Antiretroviral Therapy Interruption(ATI)Study participants will be taken off antiretroviral therapy and blood samples will be collected during each clinic visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject who were infused with the investigational product AGT103-T in the AGT168 clinical trial
Key inclusion criteria (22 listed)
- Successful engraftment of AGT103-T with at least 30 days post-infusion safety monitoring during the AGT-HC-168 Parent Study.
- Note: Successful engraftment is defined as detectable levels of AGT103-T cells bearing the AGT103 lentivirus vector.
- HIV <50 copies of viral RNA/mL plasma on stable ART.
- Continuation on the same ART regimen during the AGT-HC-168 Parent Study unless change in treatment with ART regimen is medically indicated.
- CD4 T cell count >400 cells/mm3.
Key exclusion criteria (16 listed)
- Any Grade 3 or higher drug product-related AE in the AGT-HC-168 Parent Study (participant may be enrolled once AE resolved).
- Any change in health status that would exclude enrollment in the AGT-HC-168 Parent Study.
- Active viral hepatitis B or hepatitis C infection. A complete hepatitis B virus (HBV) screen (B core antibody, HBV surface antibody, and HBV surface antigen testing) must be completed. Viral load testing will be used in questionable cases, per the discretion of the Investigator.
- History of or current cancer or malignancy, with the exception of successfully treated basal cell carcinoma of the skin.
- Current diagnosis of New York Heart Association Grade 3 or 4 congestive heart failure, uncontrolled angina, or arrhythmias.
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 |
|---|---|---|
| Antiretroviral Therapy Interruption(ATI)Study participant that were previously infused with autologous genetically modified cell product will be taken off ART and followed closely by monitoring HIV rebound. | Other | Single group |
Primary outcome
HIV kinetics
Time frame: 3 Years
Observe for changes in the HIV viral load.
CD T cell changes
Time frame: 3year
Observe the changes in the CD4 T cells and CD8 T cells count following antiretroviral treatment interruption(ATI)
2 secondary outcomes
Assess the durability of AGT103-T gene-modified cells during and after ATI
Time frame: 3 Year
CD T cells changes
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Derived from this study: PubMed 41670418Jain A, Liou ML, Xiao L, Canepa GE. Impact of AGT103-T cell and gene therapy on intact HIV proviral reservoirs. AIDS. 2026 Jul 1;40(7):880-884. doi: 10.1097/QAD.0000000000004459. Epub 2026 Feb 11.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by American Gene Technologies International Inc. at 2 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 22 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Results are not available in the source record.
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?
HIV kinetics (time frame: 3 Years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05540964, which also lists 1 linked publication.
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 2 Dec 2022.