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Gene-Edited Stem Cell Therapy for HIV/AIDS
Study Summary
This trial will test whether it is safe to give a person with leukemia a new treatment that uses their own stem cells.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I am 75 or younger for cohort 1, and 65 or younger for cohort 2.I have had an AIDS-related infection in the last year that hasn't improved with treatment.You have a condition related to AIDS or other infections that could increase the risk of complications after the treatment, as decided by the main doctor in charge.I am HIV positive with only the R5 virus strain.I have been on HIV treatment with undetectable levels for at least a year.I have a current cancer, but skin cancers or any cancer treated successfully over 2 years ago are exceptions.I am currently using or have used steroids or drugs that affect the immune system.I have previously received an HIV vaccine or gene therapy.I am not currently on any experimental treatments or have been in a drug/device study in the last 45 days.I do not have active hepatitis B or C, and if previously infected, I have no liver cirrhosis.You have had a problem with drinking alcohol or using drugs in the past year.I have an active CMV infection affecting my eyes or other organs.I am taking AZT or maraviroc in my HIV treatment.I do not have serious heart disease or heart failure.I have a history of serious blood disorders.My virus is CXCR4-tropic.
- Group 1: Cohort 1:
- Group 2: Cohort 2:
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is this research endeavor presently welcoming new participants?
"Based on the information located at clinicaltrials.gov, this particular medical study is not presently open for enrollment. Initially posted in March 2016, it was last updated a few months ago; however, there are currently 238 other trials actively recruiting patients."
Would I qualify to partake in this experiment?
"This clinical trial is recruiting 12 HIV-positive individuals aged between 18 and 75 years to participate. In order for applicants to be considered, they must meet the following criteria: Maximum age 75 years for cohort 1 and 65 years for cohort 2., Successful G-CSF/Plerixafor mobilisation of HSPC., Donating 7.5 x 10^6 CD34+ cells per kilogram in two aphereses., Demonstrated seropositivity with an R5 strain of HIV-1 virus, but no evidence of CXCR4-tropic virus infection, On cART treatment that has rendered"
At what diverse locales is this investigation being conducted?
"At the moment, this experiment is hosted at 5 different medical centres. People located in San Francisco, Duarte and Norwalk can access these locations relatively easily. Additionally, there are also other sites that may be nearer to you; it might be beneficial to pick one close by if you plan on taking part in this clinical trial."
Is this research initiative open to participants below the age of fifty-five?
"This clinical trial is limited to patients between the ages of 18 and 75. For those younger than 18, there are 57 trials available; whereas 176 studies cater to elderly participants that exceed 65 years old."
Is the FDA's clearance granted for an infusion of SB-728mR-HSPC three days after busulfan conditioning?
"The safety rating for SB-728mR-HSPC Infusion 3 days following busulfan conditioning is 1, as this Phase 1 trial has only limited evidence to support its efficacy and security."
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