Study to Evaluate the Safety of a Gene and Cell Therapy Product in Participants With HIV That is Well-Controlled on Antiretroviral Therapy

  • End date
    Sep 20, 2022
  • participants needed
  • sponsor
    American Gene Technologies International Inc.
Updated on 20 May 2021
antiretroviral therapy
HIV Vaccine


This is a Phase 1 study to assess the safety of a gene and cell therapy for autologous donor lymphocyte infusion in HIV+ participants with well-controlled viremia on antiretroviral therapy.

Condition HIV, HIV positive, HIV infection, AIDS Vaccines, HIV (Pediatric), HIV Infections, human immunodeficiency virus, hiv disease, HIV Vaccine, hiv vaccines
Treatment AGT103-T
Clinical Study IdentifierNCT04561258
SponsorAmerican Gene Technologies International Inc.
Last Modified on20 May 2021


Yes No Not Sure

Inclusion Criteria

Male or female between 18-60 years
Documented HIV infection for 3 years
Suppression of HIV to <50 copies of viral RNA/mL plasma for 2 years. Participants who had intermittent, isolated episodes of detectable low-level viremia (<500c/mL; blips) will remain eligible. Participant must have a complete antiretroviral treatment history including past and present data on resistance to antiretroviral therapy
Agree to continue their current antiretroviral regimen during the study period unless change in treatment with antiretroviral regimen is medically indicated
Have, in the Investigator's opinion, a fully active alternative antiretroviral regimen that can be used if resistance develops to the current antiretroviral therapy regimen
CD4 T cell count >400 cells/mm3
Has adequate organ function as indicated by the following laboratory values
Hematocrit 33% or hemoglobin 13g/dL (males) and 12g/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) 60mL/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 1.0mg/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 times ULN at the time of screening
AST (SGOT) and ALT (SGPT): 3.0 times ULN
Adequate venous access, per Investigator judgement, and no other contraindications for leukapheresis
Weight (without shoes) 50 kilograms
Has the ability to understand the study and must be willing to comply with study-required procedures and visits
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
Agree to participate in the 15-year Long-Term Follow-Up study

Exclusion Criteria

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 and negative for HBV core antigen to excluded previous active hepatitis
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
Liver disease by any cause
Active or history (within 5 years prior to screening) of at least one acquired immune deficiency syndrome (AIDS)-defining complication
CD4 T cell nadir of <200 cells/mm3, if the information is available at the time of screening per medical records. If this information is unavailable, the Investigator will document this in the study source records
Cancer or malignancy that has not been in remission for at least 5 years prior to screening, with the exception of successfully treated basal cell carcinoma of the skin
Current diagnosis of congestive heart failure, uncontrolled angina, or arrhythmias
Baseline prolonged QTc (Fridericia Formula) of 450 ms or more
Any clinically significant renal, hepatic, or pulmonary disease
History of active or latent tuberculosis, regardless of treatment history
Received high dose cytoreduction therapy within 3 months prior to screening
Currently taking (or has taken within 6 months prior to screening) the antiretroviral drug Selzentry (Maraviroc)
Currently using protease inhibitors, efavirenz, or zidovudine
Prior events of hemorrhagic cystitis
Evidence of urinary outflow obstruction by history, enlarged prostate on physical exam, or use of medications for urinary outflow obstruction
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
History of hereditary angioedema, acquired angioedema, or idiopathic angioedema
History of neurological diseases
Significant laboratory values and/or chronic medical condition that in the opinion of the Investigator could impact trial participation
Received another investigational drug or device within 30 days of screening
Previously received any gene transfer therapy
History or any features on physical examination indicative of a bleeding diathesis
Use of aspirin, dipyridamole, warfarin and antithrombin inhibitors or any other medication that is likely to affect platelet function or other aspects of blood coagulation within 3 days prior to the Leukapheresis Visit
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., monoclonal antibodies, interleukin-2, interferon-alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to screening (NOTE: Use of inhaled or topical steroids is not exclusionary)
Currently pregnant or breast-feeding
Unwilling to use acceptable methods of birth control for 6 months following the infusion of AGT103-T 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
Recent vaccination or intercurrent illness within 5 weeks prior to screening (NOTE: It is recommended that participants should have completed their routine vaccinations, e.g., hepatitis A or B, pneumococcus, influenza and tetanus diphtheria booster, at least 5 weeks prior to screening for the study)
Known allergy to Dimethyl Sulfoxide (DMSO)
Known allergy to Cyclophosphamide
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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