HIV-1-infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of Zadaxin® in the treatment of HIV-positive patients with immune reconstitution disorders. Researchers previously used Zadaxin® (Thymosin α-1, Tα1) as an immune adjuvant for people infected with HIV-1 and found that Tα1 and Interferon-α (IFN-α) have a synergistic effect in immune enhancement. In addition, studies have found that the triple combination of Tα1, IFN-α and Zidovudine has better tolerability, safety and efficacy. After treatment, patients have lower HIV RNA and more stable high CD4+ T cell counts. In addition, extensive studies on the administration of Tα1 in thymectomized mice have demonstrated its ability to promote immune reconstitution. The researchers hypothesized that Zadaxin® has a better therapeutic effect on HIV-positive patients with immune reconstitution disorders, can increase the CD4+T cell count, reduce the viral load, and has better safety.
Detailed description
All patients received Zadaxin (1.6 mg subcutaneous injection, once a day) in the first 2 weeks, and changed frequency (1.6 mg subcutaneous injection, twice a week) in the successive 22 weeks. It is still recommended to continue treatment until the end of the study. All subjects were given HAART treatment throughout. In 4th week, 8th week, 12th week and 24th week, perform 4 follow-up and record the changes in CD4+ T cell count and proportion, CD8+ T cell count and proportion, proportions of T cell subsets, PBMC sjTREC, proportions of exhauseted T cell expressed PD-1 and Tim-3, and HIV viral load. During the process, safety assessment is performed, including adverse events, electrocardiogram and a series of laboratory tests (blood routine, liver and kidney function, etc.).
Interventions
DRUGZadaxin
1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the successive 22 weeks.
Sponsors
Shanghai Public Health Clinical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All participants eligible for study received the same open label drug
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-65 years old; * HIV serology is positive; * Volunteer to participate; * CD4+T cell count \>100 and \<350 cells/mm3; * People who have received HAART treatment and the viral load is undetected for at least 2 years, but have immune reconstitution disorder; * Without active opportunistic infection;
Exclusion criteria
* History of allergy or contraindications to Zadaxin; * Skin basal cell carcinoma, cervical carcinoma in situ or other concurrent tumors other than Kaposi's sarcoma; * The expected survival time is less than 1 year; * Women of childbearing age have a positive pregnancy test; * Major heart disease or central nervous system disease or other nervous system abnormalities; * ACTG-AIDS dementia syndrome staging score\> 0.5; * Organ transplantation; * Received chemotherapy and radiotherapy for malignant tumors within 6 months; * Known immunomodulators (such as systemic steroids, interferons, interleukins) or other immunotherapy within 30 days before the start of the study; * Blood transfusion within 30 days before the start of the study; * Have a history of iritis, endophthalmitis, scleritis or retinitis; * Within 30 days before the screening assessment, accept any experimental treatment for HIV-positive patients with or without symptoms of infection; * Drug abuse; * The doctor's decision is that participation in the trial is not in the patient's best interests, or any situation that does not allow safe compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CD4+T cell counts | Measured on week 24 | Peripheral blood |
| Change in CD4/CD8 ratio | Measured on week 24 | Peripheral blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in proportions of T cell subsets | Measured on week 0, 4, 8, 12, 24 | Peripheral blood mononuclear cell |
| Change in proportions of immune exhausted T cells expressed PD-1 and TIM-3 | Measured on week 0, 4, 8, 12, 24 | Peripheral blood mononuclear cell |
| Change in CD4+T cell count and proportion | Measured on week 0, 4, 8, 12, 24 | Peripheral blood |
| Change in HIV-1 RNA | Measured on week 0, 4, 8, 12, 24 | Plasma |
| Change in PBMC sjTREC | Measured on week 0, 4, 8, 12, 24 | Peripheral blood mononuclear cell |
| Change in CD8+T cell count and proportion | Measured on week 0, 4, 8, 12, 24 | Peripheral blood |
Countries
China
Outcome results
None listed