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

NCT06117657 | Unknown Early Phase 1

• 1 other identifier: CP-Tri01-001/01
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Concentration and titer of serum neutralizing antibodies

  Day 0 through 52 Weeks after KL-HIV-Tri01 administration

• CD4+T, CD8+T cell count

  Day 0 through 52 Weeks after KL-HIV-Tri01 administration

• viral load

  Day 0 through 52 Weeks after KL-HIV-Tri01 administration

• Time to interrupt HAART treatment

  Day 0 through 52 Weeks after KL-HIV-Tri01 administration

Study Arms (1)

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.

Drug: Low dose KL-HIV-Tri01; Drug: Middle dose KL-HIV-Tri01; Drug: High dose KL-HIV-Tri01

Interventions

Low dose KL-HIV-Tri01 DRUG

Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10\^11 vg/kg.

Also known as: rAAV vector

KL-HIV-Tri01 injection solution

Middle dose KL-HIV-Tri01 DRUG

Subjects will be dosed with single dose of KL-HIV-Tri01 at 8.0x10\^11 vg/kg.

Also known as: rAAV vector

KL-HIV-Tri01 injection solution

High dose KL-HIV-Tri01 DRUG

Subjects will be dosed with single dose of KL-HIV-Tri01 at 2.4x10\^12 vg/kg.

Also known as: rAAV vector

KL-HIV-Tri01 injection solution

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (not inclusive) to 80 (inclusive) years of age, both male and female.
• \. Conform to the Chinese AIDS Diagnosis and Treatment Guidelines (2021), HIV positive, and received HAART treatment for ≥ 3 months before enrollment.
• \. CD4+T cell count≥500 cells/μl.
• \. On a stable antiretroviral regimen before enrollment and viral load less than 40 copies/mL in two consecutive tests one year prior to enrollment.
• \. 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.

You may not qualify if:

• 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.
• Active viral infections, such as HBV, HCV, CMV, or other viruses that the investigator believes will affect clinical research.
• Any opportunistic infection in the past one year, such as tuberculosis, cryptococcosis, which is not cured after treatment.
• Currently treated with Immunosuppressive medications or steroids.
• Previous receipt of HIV vaccine, antibody or gene therapy.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Honghua He, MD

  Affiliated Hospital of Guangdong Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Honghua He, MD

CONTACT

+86 138 2822 9695; 192880@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated chief physician

Model Details: 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;

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 10, 2023
• Primary Completion: August 20, 2024
• Study Completion: September 10, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share