Allogeneic immune therapy for advanced AIDS patients
Safety and Efficiency of Allogeneic Adoptive Immune Therapy for Advanced AIDS Patients
This study is testing a new immune therapy to see if it can help advanced AIDS patients with low immune cell counts feel better and reduce serious health risks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing 302 Hospital Academic / other |
| Drugs / interventions | cART |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04098770 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of allogeneic adoptive immune therapy in advanced AIDS patients who have a CD4+ T cell count of less than 200 cells/µL. The study aims to address the high mortality rates associated with opportunistic infections and severe complications in this patient population, which have not been effectively treated with current therapies. Participants will receive immune therapy designed to restore their immune function, potentially improving their overall health outcomes. The trial will include patients who have not previously participated in other clinical trials during the study period.
Who should consider this trial
Good fit: Ideal candidates are advanced AIDS patients aged 18 to 65 with a CD4 count of 200 cells/µL or less.
Not a fit: Patients with serious organic diseases unrelated to AIDS or those currently undergoing long-term immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve immune function and reduce mortality in advanced AIDS patients.
How similar studies have performed: While there have been exploratory uses of immune therapies in AIDS patients, this specific approach is novel and has not been extensively tested in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female, aged at 18 years (including) -65 years old 2. Advanced AIDS patients with AIDS-related events 3. Advanced patients with CD4 count less than or equal to 200 cells/uL, including end-stage patients with CD4 count less than or equal to 50 cells/uL before entry and at screening 4. Sign informed consent, do not participate in other clinical trails during the period Exclusion Criteria: 1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures 2. Combined with other serious organic diseases while didn't related with AIDS 3. HIV-2 infection 4. Allergic to blood products 5. Under long term immunosuppressive therapy 6. Combined with malignant tumors 7. Drug addicts within half-one year before the test 8. Poor compliance to antiviral therapy; take part in other clinical trials at present
Where this trial is running
Beijing, Beijing
- Beijing 302 Hospital of China — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Ruonan Xu, MD
- Email: xuruonan2004@aliyun.com
- Phone: 86-10-66933333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.