BridgeMD
Tests treatment safety and results for HIV Infected Individuals
Official title The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS Patients
ClinicalTrials.gov ID: NCT06880380
What this study is testing
What is HIV-CAR-T?
HIV-CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hiv infected individuals.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Autologous CAR-T cell therapy in HIV-1/AIDS patients
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age between 18 and 65 years;
- Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels \<50 copies/mL for...
- CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
- Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the...
- Willingness to provide true identity information and comply with follow-up requirements;
You likely can't join if
- Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
- Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
- History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis...
- Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid...
- Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory...
- Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions...
See the full eligibility criteria
- Age between 18 and 65 years;
- Confirmed diagnosis of HIV-1 infection, with regular antiviral therapy ≥24 months prior to enrollment and sustained HIV-RNA levels \<50 copies/mL for the 12 months preceding enrollment;
- CD4+ T-cell count \>350/μl within 30 days prior to enrollment;
- Female participants of childbearing potential (including those ≤50 years old who are amenorrheic) must have a negative urine pregnancy test; from the screening period until the end of the study, participants should have...
- Willingness to provide true identity information and comply with follow-up requirements;
- Ability to fully understand the study objectives, procedures, and potential risks, voluntary signing of an informed consent form, and adherence to the study requirements.
- Women who are pregnant, breastfeeding, or of childbearing potential unwilling/unable to use effective contraception.
- Coinfection with other viruses or infections, including HIV-2, HAV, HBV, HCV, HDV, HEV, EBV, CMV, or syphilis.
- History of AIDS-related opportunistic infections or malignancies within the past year (e.g., candidiasis, coccidioidomycosis, cryptococcosis, cytomegalovirus disease, herpes simplex, lymphoma).
- Autoimmune diseases requiring systemic immunosuppressive/immunomodulatory therapy within the past 2 years (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus).
- Severe non-AIDS-related comorbidities, including uncontrolled clinically significant diseases of the genitourinary, cardiovascular, respiratory, neurological, psychiatric, gastrointestinal, endocrine, immune systems, or...
- Central nervous system (CNS) disorders, such as epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, or autoimmune conditions involving the CNS.
- Suspected or confirmed history of alcohol abuse, drug addiction, illicit substance use, or psychiatric disorders.
- Abnormal laboratory results within 14 days prior to enrollment meeting any of the following: Hemoglobin \ 110 μmol/L INR \>1.5 or PTT \>45 seconds ALT or AST \>2.5 × upper limit of normal (ULN) Total bilirubin \>1.5 ×...
- Current participation in another clinical trial that may conflict with the current protocol or outcome assessments.
- Any other condition deemed inappropriate for participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.