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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-10

Study Completion Date

2025-09-10

Brief Summary

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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.

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Detailed Description

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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 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.

Conditions

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HIV Infections

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

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;

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KL-HIV-Tri01 injection solution

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.

Group Type EXPERIMENTAL

Low dose KL-HIV-Tri01

Intervention Type DRUG

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

Middle dose KL-HIV-Tri01

Intervention Type DRUG

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

High dose KL-HIV-Tri01

Intervention Type DRUG

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

Interventions

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Low dose KL-HIV-Tri01

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

Intervention Type DRUG

Middle dose KL-HIV-Tri01

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

Intervention Type DRUG

High dose KL-HIV-Tri01

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

Intervention Type DRUG

Other Intervention Names

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rAAV vector rAAV vector rAAV vector

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No