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This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution in HIV infected subjects treated with HAART.
This is an open- label, non- randomized, uncontrolled, dose-escalation pilot study to evaluate the safety and efficacy of KL-HIV-Tri01 injection solution expressing triple targets antibodies with broad HIV-1 neutralizing activity in HIV-1 infected adults on anti-retroviral therapy (ARV). Nine subjects will be enrolled and administered with three different doses of KL-HIV-Tri01. Subjects will provide informed consent and then undergo screening assessments up to 1 month prior administration of KL-HIV-Tri01. All subjects will undergo 52 weeks safety observation and will be encouraged to enroll in an extension study to evaluate long- term safety of KL-HIV-Tri01 for total 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KL-HIV-Tri01 injection solution | Experimental | Subjects will be dosed with three different dose of KL-HIV-Tri01 injection solution at 2.4x10^11 vg/kg to 2.4x10^12 vg/kg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose KL-HIV-Tri01 | Drug | Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^11 vg/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of AEs and SAEs | AEs and SAEs from the date of product administration will be recorded through the last study visit. The relationship between AEs and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| Neutralizing Antibodies Against KL-HIV-Tri01 Capsid | Anti-KL-HIV-Tri01 Capsid antibodies were analyzed by enzyme-linked immunosorbent assay (ELISA) using a vector-matched AAV capsid as the capture agent. | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| Inhibitors of broadly neutralizing antibodies | Inhibitors against broadly neutralizing antibodies expressed by KL-HIV-Tri01 were analyzed by enzyme-linked immunosorbent assay (ELISA) . | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| Cells mediated immune response against capsids and bNabs | Number of participants with T-cell response to AAV capsid and transgene products was planned to be reported. | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration and titer of serum neutralizing antibodies | The serum concentration and titer of neutralizing antibodies produced by KL-HIV-Tri01 at specified time intervals for 52 weeks after dosing was determined | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| CD4+T, CD8+T cell count |
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Inclusion Criteria:
1.18 (not inclusive) to 80 (inclusive) years of age, both male and female.
2. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
3. CD4+T cell count≥500 cells/μl.
4. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
5. Willing to fully understand the purpose, nature, method, and potential adverse reactions that may occur during the discontinuation period of the experiment, voluntarily participate in this experiment and sign an informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Honghua He, MD | Contact | +86 138 2822 9695 | 192880@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Honghua He, MD | Affiliated Hospital of Guangdong Medical University | Principal Investigator |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Low dose group will be administrated with 2.4×10^11 vg/kg; Middle dose group will be administrated with 8.0×10^11 vg/kg; High dose group will be administrated with 2.4×10^12 vg/kg;
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| Middle dose KL-HIV-Tri01 | Drug | Subjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10^11 vg/kg. |
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| High dose KL-HIV-Tri01 | Drug | Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^12 vg/kg. |
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The clinical effects of KL-HIV-Tri01 on CD4+T and CD8+T cell count were assessed. CD4+T and CD8+T Cell Count (cells/mL) shown as reported by the Clinical Center serology lab |
| Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| viral load | The clinical effects of KL-HIV-Tri01 on viral load were assessed after interruption of HAART. | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| Time to interrupt HAART treatment | The duration of anti-HIV replication effection of the neutralizing antibodies produced by KL-HIV-Tri01were assessed after interruption of HAART. | Day 0 through 52 Weeks after KL-HIV-Tri01 administration |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |