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An Antiretroviral Treatment Interruption(ATI) Study to Evaluate the Impact of AGT103-T to Suppress Human Immunodeficiency Virus Replication in the Absence of Antiretroviral Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05540964
Recruitment Status : Enrolling by invitation
First Posted : September 15, 2022
Last Update Posted : September 15, 2022
Information provided by (Responsible Party):
American Gene Technologies International Inc.

Brief Summary:
To test the hypothesis that AGT103-T cells therapy will allow HIV positive individual to reduce, modify or eliminate antiretroviral therapy.

Condition or disease Intervention/treatment Phase
HIV Other: Antiretroviral Therapy Interruption(ATI) Phase 1

Detailed Description:
Study subject who have been infused with AGT103-T in a prior trial (AGT-HC-168) will be invited to stop their antiretroviral therapy and be 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 decrease in their CD4 lymphocyte number.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All study participant that consent to the study will be withdrawn from their Antiretroviral Therapy(ART) and monitored closely by clinic visit and laboratory testing of blood sample collected during each visit.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : July 19, 2022
Estimated Primary Completion Date : July 19, 2025
Estimated Study Completion Date : July 19, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Single group
Study participants will be taken off antiretroviral therapy and blood samples will be collected during each clinic visit.
Other: 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.

Primary Outcome Measures :
  1. HIV kinetics [ Time Frame: 3 Years ]
    Observe for changes in the HIV viral load.

  2. 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)

Secondary Outcome Measures :
  1. Assess the durability of AGT103-T gene-modified cells during and after ATI [ Time Frame: 3 Year ]
    Measure the AGT103-T gene-modified cell during and after ATI

  2. CD T cells changes [ Time Frame: 3 Years ]
    Measure changes in frequency of Gag-specific CD4 and CD8 T cells following ATI

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. 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.

  2. HIV <50 copies of viral RNA/mL plasma on stable ART.
  3. Continuation on the same ART regimen during the AGT-HC-168 Parent Study unless change in treatment with ART regimen is medically indicated.
  4. CD4 T cell count >400 cells/mm3.
  5. Ability to understand the study and willingness to comply with study-required procedures and visits.
  6. Written informed consent signed and dated by the study participant.
  7. 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.
  8. Unless medically prescribed, a negative drug test for amphetamines; barbiturates; benzodiazepines; cocaine; methadone (Dolophine®); opiates (codeine, morphine only); phencyclidine (PCP); propoxyphene.
  9. 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.
  10. 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.
  11. 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.

  12. 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

Exclusion Criteria

  1. Any Grade 3 or higher drug product-related AE in the AGT-HC-168 Parent Study (participant may be enrolled once AE resolved).
  2. Any change in health status that would exclude enrollment in the AGT-HC-168 Parent Study.
  3. 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.
  4. History of or current cancer or malignancy, with the exception of successfully treated basal cell carcinoma of the skin.
  5. Current diagnosis of New York Heart Association Grade 3 or 4 congestive heart failure, uncontrolled angina, or arrhythmias.
  6. Any clinically significant renal, hepatic, or pulmonary disease.
  7. Is being treated for culture-confirmed bacteremia or had culture-confirmed bacteremia within 1 month prior to screening.
  8. Has signs or symptoms of acute infectious disease.
  9. Significant laboratory values and/or chronic medical condition that in the opinion of the Principal Investigator could impact trial participation.
  10. Currently pregnant or breast-feeding.
  11. 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.
  12. Active alcohol use or dependence that, in the opinion of the Investigator, would interfere with adherence to study requirements.
  13. Serious illness requiring systemic treatment and/or hospitalization within 30 days prior to screening.
  14. Subject is unwilling to agree to practice safe sex or share needles.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05540964

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United States, District of Columbia
Georgetown University
Washington, District of Columbia, United States, 20007
Washington Health Institute
Washington, District of Columbia, United States, 20017
Sponsors and Collaborators
American Gene Technologies International Inc.
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Responsible Party: American Gene Technologies International Inc.
ClinicalTrials.gov Identifier: NCT05540964    
Other Study ID Numbers: AGT-HC-169
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by American Gene Technologies International Inc.:
Gene Therapy
Genetically modified CD4 T cells
Antiretroviral therapy interruption
Lentivirus vector
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents