Developing a Functional Cure for HIV Disease: Clinical Specimen Collection From HIV Positive Individuals

  • STATUS
    Recruiting
  • days left to enroll
    74
  • participants needed
    24
  • sponsor
    American Gene Technologies International Inc.
Updated on 20 September 2020
Investigator
Gerome Burke, M.D., Ph.D.
Primary Contact
Providence Hospital (3.3 mi away) Contact
+1 other location
antiretroviral agents
antiretroviral therapy
viremia

Summary

Clinical specimens are required from HIV positive individuals with viremia controlled by antiretroviral therapy to complete process development for a genetically modified autologous T cell product, AGT103-T. The product will be used in a subsequent early stage clinical trial in subjects with chronic HIV disease and viremia suppressed by antiretroviral therapy as the initial step in testing a functional cure for HIV disease. Enrolled participants provide a venous blood specimen (approximately 25mL) to determine their level of HIV-reactive CD4+ T cells. Subjects with positive T cell responses will be asked to undergo leukapheresis and their clinical specimens will be used to validate and qualify the AGT103-T cell product.

Description

This protocol is to collect blood specimens from HIV positive individuals. The first blood draw will be done at the first study visit and if eligible, the second blood collection will be done via leukapheresis at the second visit. The leukapheresis procedures will follow the facility's standard operating procedures and protocol requirements for leukapheresis.

Volunteers will be males or females between and including the ages of 18 years and 60 years. Volunteers will provide written informed consent and meet all inclusion and exclusion criteria. Each participant can be in the study for up to 120 days (3 months).

The study will be conducted in accordance with GCP/ICH for human research for the purposes of obtaining clinical specimens for research. There is no endpoint for this study, however, data collected from this study will include, but not be limited to, gender, demographics, medical history, clinical laboratory values, and volume of the blood collected. The data will be summarized in future studies reporting results from a planned clinical trial.

Details
Clinical Study IdentifierNCT03215004
SponsorAmerican Gene Technologies International Inc.
Last Modified on20 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 60 yrs?
Gender: Male or Female
Do you have any of these conditions: Primary Immunodeficiency Disorders or HIV Infections or HIV infection or Immunodeficiency?
Male or female aged between 18 and 60 years
Documented HIV infection for at least 3 years prior to study entry
Stable on HIV antiretroviral regimen with viral suppression to <50c/mL plasma for >2 years
Agrees not to change antiretroviral regimen (unless medically indicated) during the study period
CD4+ T cell count >500 cell per millimeter cubed (cells/mm3) at last measurement within 6 months of study participation
CD4+ T cell nadir of >350 cells/mm3
HIV plasma viral load <50 copies of viral RNA per milliliter (mL) for >2 years
Participants who had intermittent, isolated episodes of detectable low-level viremia (<500c/mL; blips) will remain eligible
Have not received cytoreduction therapy within 3 months of study entry
Do not have prior events of hemorrhagic cystitis
Is not being treated or does not have bacteremia within the past 6 months
Does not have signs or symptoms of acute infectious disease
Adequate venous access and no other contraindications for leukapheresis
Hematocrit is >33% or hemoglobin is 13g/dL (males) and 12g/dL (females) at last measurement within 7 days prior to study enrollment; test also required within 3 days prior to leukapheresis
Weighs more than 75 lbs
Not pregnant at time of enrollment
Ability to understand the study and must be willing to comply with study-required procedures and visits, including only changing antiretroviral regimen when indicated by the study doctor during the study period
Written informed consent signed and dated by study participant

Exclusion Criteria

Acute or chronic hepatitis B or hepatitis C infection with detectable viremia
Any viral hepatitis or liver disease (e.g. cirrhosis)
Active or recent (prior 6 months) AIDS defining complication
Any experimental HIV medications within the past 12 weeks
Cancer or malignancy that has not been in remission for at least 5 years with the exception of successfully treated basal cell carcinoma of the skin
Current diagnosis of NYHA grade 3 or 4 congestive heart failure or uncontrolled angina or arrhythmias
Any clinically significant renal, hepatic, and pulmonary disease
Inadequate venous access or contraindicated for leukapheresis
Significant laboratory values and/or a chronic medical condition that, in the opinion of the Principal Investigator, could impact trial participation
Receiving another investigational drug or device within 30 days of study entry
Previously received any gene transfer therapy
History or any features on physical examination indicative of a bleeding diathesis
Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g. 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)
Breast-feeding or pregnant
Use of aspirin, dipyridamole, warfarin or any other medication that is likely to affect platelet function or other aspects of blood coagulation during the 2-week period prior to leukapheresis
Active drug or 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 study entry
Recent vaccination or intercurrent illness within 5 weeks prior to T cell infusion (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 30 days prior to screening for the study)
Asplenia: any conditions resulting in the absence of a functional spleen
History of hereditary angioedema, acquired angioedema or idiopathic angioedema
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