An Efficacy and Safety Study of shRNA-modified CD34+ Cells in HIV-infected Patients.

• Status: Recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of autologous CD34+ cells that stably express multiplexed shRNA to treat HIV infection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Public Health Clinical Center
• Collaborators: Kanglin Biotech (Hangzhou) Co. LTD; R&D Kanglin Biotech
• Treatments: Busulfan

Criteria

Inclusion Criteria:

• Body mass index (BMI) from 18 - 25; body weight ≥50kg.

• Diagnosis of HIV infections/AIDS based on "Diagnostic Criteria for HIV/AIDS" WS 293-2008.

• No antiretroviral therapy (ART) in the past 6 weeks and refuse to receive ART.

• CD4 T cell count ≥350/μl.

• No plan for pregnancy in the near future and agree to practice non-drug based contraception.

• Voluntary to participate in the study, comply with the study design to complete all monitory measurements, and agree to sign the study agreement.

Exclusion Criteria:

• Existence of infections/opportunistic tumors.

• Mutations in the shRNA target sequences.

• White blood cell count <3x10^9/L, neutrophil count <1.5x10^9/L, hemoglobin <110g/L, platelet count <100x10^9/L.

• Liver diseases (HBV, chronic HCV infection, congenital liver metabolic disease), abnormal liver functions (test value 2x above normal).

• Kidney deficiency (Creatinine level above the upper limit of normal levels).

• Severe chronic disease, metabolic disease (e.g., diabetes), neurological and psychiatric diseases.

• History of pancreatitis.

• Women in pregnancy, lactating or at reproductive age who do not practice contraception.

• Allergy to agents or drugs used in the study.

• Verified or suspected abuse of alcohol and drugs.

• Participated in other clinical trials within 3 months.

• Based on investigator's assessment, those who are unfit for the study (e.g., general weakness, poor compliance with study design).

• Personal or family history of tumors.