CD4 CAR+ ZFN-modified T Cells in HIV Therapy
- Conditions
- Hiv
- Registration Number
- NCT03617198
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria:<br><br> - HIV-1 infection<br><br> - Clinically stable on first or second HAART regimen<br><br> - Screening CD4+ T cell count of =450 cells/mm3 within 30 days of enrollment; and a<br> documented CD4 nadir of not lower than 200 cells/mm3<br><br> - Screening HIV-1 RNA that is =50 copies/mL within 30 days prior to enrollment<br><br> - HIV-1 RNA =50 copies/mL for at least 24 weeks prior to enrollment<br><br> - Adequate venous access and no other contraindications for leukapheresis<br><br> - Laboratory values within certain parameters, obtained within 30 days prior to<br> enrollment<br><br> - Willing to comply with study-mandated evaluations<br><br> - Male or female, 18 years of age or older<br><br> - Ability and willingness to provide informed consent<br><br> - Karnofsky Performance Score of 70 or higher<br><br> - Negative HBsAg (hepatitis B) within 6 months prior to enrollment<br><br> - Negative HCV (hepatitis C) serology, or if positive, negative HCV RNA within 6<br> months prior to enrollment<br><br> - Have a recorded viral load set point prior to starting antiretroviral therapy<br><br>Exclusion Criteria:<br><br> - Acute or chronic hepatitis B or hepatitis C infection<br><br> - Current or prior AIDS diagnosis<br><br> - History of cancer or malignancy, with the exception of successfully treated basal<br> cell or squamous cell carcinoma of the skin<br><br> - History or any features on physical examination indicative of active or unstable<br> cardiac disease or hemodynamic instability (subjects with a history of cardiac<br> disease may participate with a physician's approval)<br><br> - History or any features of physical examination indicative of bleeding diathesis<br><br> - Have been previously treated with any HIV experimental vaccine within 6 months prior<br> to screening, or any previous gene therapy using an integrating vector (subjects<br> treated with placebo in an HIV vaccine study will not be excluded if documentation<br> that they received placebo is provided)<br><br> - Use of chronic systemic corticosteroids, hydroxyurea, or immunomodulating agents<br> within 30 days prior to enrollment (recent or current use of inhaled steroids is not<br> exclusionary)<br><br> - Breast-feeding, pregnant, or unwilling to use acceptable methods of birth control<br><br> - Anticipated use of aspirin, dipyridamole, warfarin, or any other medication that is<br> likely to affect platelet function or other aspects of blood coagulation during the<br> 2 week period prior to leukapheresis<br><br> - Active drug or alcohol use or dependence that, in the opinion of the investigator,<br> would interfere with adherence to study requirements<br><br> - Serious illness requiring systemic treatment and/or hospitalization within 30 days<br> prior to the study screening visit<br><br> - Receipt of vaccination within 30 days prior to study screening visit<br><br> - Have an allergy to hypersensitivity to study product components (human serum<br> albumin, DMSO and Dextran 40)<br><br> - Currently taking a non-nucleoside reverse transcriptase inhibitor (NNRTI)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of subjects with treatment related adverse events.
- Secondary Outcome Measures
Name Time Method Compare the percentage of enriched modified CD4 CAR+ CCR5 ZFN cells and their subsets.;Compare the change in CD4 count.;Compare viral set point log 10 HIV RNA level.;Percentage of cells producing cytokines in response to HIV antigen/peptide as assessed by flow cytometry;Size of latent HIV reservoir as assessed by quantification of integrated copies of replication competent HIV;Sequence of HIV envelope genes and coreceptor usage in breakthrough HIV infections;Number of participants who control HIV replication that have similar gene expression patterns as determined by RNA quantification