Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects

HIV Infections Clinical Trial

Official title:

Safety and Efficacy Clinical Study of KL-HIV-Tri01 in the Treatment of HIV Infected Subjects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06117657
• Other study ID #: CP-Tri01-001/01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: November 10, 2023
• Est. completion date: September 10, 2025

Study information

• Verified date: November 2023
• Source: Affiliated Hospital of Guangdong Medical University
• Contact: Honghua He, MD
• Phone: +86 138 2822 9695
• Email: 192880[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: September 10, 2025
• Est. primary completion date: August 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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:

1. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.

2. Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.

3. Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.

4. Currently treated with Immunosuppressive medications or steroids.

5. Previous receipt of HIV vaccine, antibody or gene therapy.

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Low dose KL-HIV-Tri01
Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^11 vg/kg.
• Middle dose KL-HIV-Tri01
Subjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10^11 vg/kg.
• High dose KL-HIV-Tri01
Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10^12 vg/kg.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Guangdong Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	CD4+T, CD8+T cell count	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
Secondary	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
Secondary	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