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COMPLETEDPHASE1

Redirected MazF-CD4 Autologous T Cells for HIV Gene Therapy

A Phase I, Open Label, Dual Cohort, Single Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Autologous CD4 T Cells Modified With a Retroviral Vector Expressing the MazF Endoribonuclease Gene in Patients With HIV

NCT01787994•University of Pennsylvania

View on ClinicalTrials.gov

Summary

This is an open label, dual cohort study evaluating safety, tolerability and immunogenicity of redirected CD4+ T cells in HIV subjects.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. HIV-1 infection, as documented by a rapid HIV test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by Western blot at any time prior to study entry. Alternatively, if a rapid HIV test or any FDA-approved HIV-1 enzyme or chemiluminescence immunoassay (E/CIA) test kit is not available, two HIV-1 RNA values \>2000 copies/mL at least 24 hours apart performed by any laboratory that has CLIA certification, or its equivalent, may be used to document infection.
•2. Antiretroviral medication
•* Cohort 1: Subjects on HAART (no changes to treatment within 4 weeks of study entry) for at least 3 months.
•* Subjects on HAART (no changes to treatment within 4 weeks of study entry) for at least 3 months.
•3. Plasma HIV viremia
•* Cohort 1: HIV-1-positive men and women \>18 years of age with HIV-1-RNA levels undetectable by ultrasensitive HIV PCR Abbott assay at screening. Also eligible are subjects with HIV-1 RNA \< 400 copies/mL; however, the HIV-1 RNA must be \< 50 copies/mL within 60 days prior to study entry based on the Abbott assay. Subjects with intermittent isolated episodes of detectable low level viremia (\> 50 but \<1,000 copies RNA/mL; blips) will be eligible. There should be at least 2 documented HIV-1 RNA assays, one drawn \>3 months before study entry, one drawn \<3 months before study entry.
•* Cohort 2: HIV-1-positive men and women \>18 years of age with HIV-1-RNA levels undetectable by ultrasensitive HIV PCR assay at screening. Note: Due to sensitivity issues using the Roche Assay and the fact that we cannot control the HIV testing technique prior to enrollment, we decided to consider subjects with HIV-1 RNA \< 400 copies/mL; however, the HIV-1 RNA must be undetectable within 60 days prior to study entry based on the ultrasensitive HIV PCR assay. Subjects with intermittent isolated episodes of detectable low level viremia (\> 50 but \<1,000 copies RNA/mL; blips) will be eligible. There should be at least 2 documented HIV-1 RNA assays: one drawn \>3 months before study entry, one drawn \<3 months before study entry.
•4. CD4 counts
•* Cohort 1: Subjects with CD4 counts \>350 cells/mm3.
•* Cohort 2: Subjects with CD4 counts of at least 450 cells/mm3 at screening. Note: CD4 nadir in Cohort 2 must be above 200 cells/mm3.
+11 more criteria

Exclusion Criteria

•1. No history of opportunistic infections or neoplasm.
•2. Concomitant acute or chronic hepatitis B (surface antigen positive) or hepatitis C infection. If HCV antibody test is positive, an HCV RNA test will be performed. If both HCV tests (antibody and RNA) are positive, the subjects will be excluded from study. If HCV antibody test is positive, but HCV RNA test is negative, subject can enroll. Results should be obtained no more than 30 days prior to screening.
•3. History of cancer or malignancy, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin.
•4. 4.2.4 History or any features on physical examination indicative of active or unstable cardiac disease or hemodynamic instability.
•5. History or any features on physical examination indicative of a bleeding diathesis.
•6. Have been previously treated with any HIV experimental vaccine within 6 months prior to screening, or any previous gene therapy using an integrating vector.
•7. 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 study entry.
•8. Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control.
•9. Use of aspirin, dipyrdamole, 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.
•10. Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
+5 more criteria

Locations (1)

Division of Infectious Diseases & HIV Medicine at Drexel University College of Medicine

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

December 1, 2012

Primary Completion Date

July 1, 2017

Completion Date

July 1, 2017

Last Updated

August 30, 2019

Enrollment

ACTUAL participants

Conditions

HIV

Interventions

Autologous CD4+ T cells genetically modified with a retroviral vector expressing the MazF endoribonuclease gene (MazF-T), given via intravenous infusion.

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 30, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Redirected MazF-CD4 Autologous T Cells for HIV Gene Therapy

Inclusion Criteria

Exclusion Criteria

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